PRODUCT
QUALITY (Certificate of Analysis)
(In
alphabetical sequence)
(
A ----> K ) (
L ----> Z )
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ZXFPC0001
10-Deacetyl Baccatin III
CAS Number: 32981-86-5
10-DAB III
Appearance: White powder
Quality Index Standard Results
Identification: FT-IR, HPLC, NMR, Mass Positive
Melting Point: 234--246℃ 234.5-245.5℃
Loss on drying: ≤1.0％ 0.5%
Residue on ignition:
1, Ethyl alcohol: ≤0.001％ Conforms
2, Haxane: ≤0.002％ Conforms
3, Acetic ester: ≤0.001％ Conforms
Heavy metals: 1, Pb: ≤10-7 Conforms
2, Cu: ≤10-7 Conforms
3, Zn: ≤10-7 Conforms
4, Cd: ≤10-7 Conforms
5, Hg: ≤10-7 Conforms
Impurities: Cephalomannine ≤0.5％ Conforms
Paclitaxel ≤0.5％ Conforms
Total Impurities: ≤1.0％ Conforms
Assay(by HPLC): ≥99.0% 99.30%
Conclusion: The Specification conforms the Enterprise Standard.
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ZXFPC0014
5'-Deoxy-5-Fluorouridine
CAS Number: 3094-09-5
5'-Deoxy-5-Fluorouridine
Appearance: White crystalline powder
Quality Index Standard Results
Identification: Rule of ES Conforms
UV Assay: >98% 99.5%
E250-260: 0.59-0.65 0.64
E280-260: 0.85-0.91 0.90
E290-260: 0.35-0.41 0.40
HPLC Purity: 98.0---101.0% 99.23%
Loss on drying: ≤1.0% 0.30%
PH Determination: 4.2-5.1 4.50
Melting point: 189--192℃ 190.5-191.4℃
Residue Solvent: ≤1.0% 0.06%
Arsenium: ≤2ppm <2ppm
Residue on ignition: ≤0.1% 0.07%
Optical rotation: 365nm(1%) +157?--+171? +167?
589nm(1%) +18?--+20? +18.5?
Chlorides: ≤0.035% Conforms
Related substances: Rule of ES Conforms
Heavy metals: ≤20ppm <20ppm
Foreign Matters: Not found Conforms
Conclusion: The Specification conforms to the rule of Enterprise Standard.
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ZXFPC0016
7-Ethyl-10-Hydroxy Camptothecine
CAS Number: 86639-52-3
7-Ethyl-10-Hydroxy Camptothecin
Appearance:Pale yellow Powder
Quality Index Standard Results
Melting point: 215--216℃ 215℃
Sulphate Ash: ≤0.1％ 0.05%
Loss on drying: ≤1.0％ 0.56%
Assay(By HPLC): ≥98% 99.24%
Conclusion: The Specification conforms to the rule of Enterprise Standard.
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ZXFPC0028
Adefovir Dipivoxil
CAS Number: 142340-99-6
Adefovir Dipivoxil (Adefovir)
Appearance: White or almost white crystalline powder
Quality Index Standard Results
Identification: Rule of ES Conforms
Melting point: 149--151℃ 150-151℃
Specific rotation: +12?--+14? +13?
Loss on drying: ≤0.5% 0.2%
Residue on ignition: ≤0.1% Conforms
Heavy metals: ≤10ppm <10ppm
Sulphated Ash: ≤0.1% 0.07%
Related substances: Rule of ES Conforms
Assay: 98.0---102.0% 99.4%
Conclusion: The Specification conforms to the rule of Enterprise Standard.
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ZXFPC0029
Adenine
CAS Number: 73-24-5
Adenine
Appearance: White or almost white crystalline powder
Quality Index Standard Results
Identification: Rule of USP26 Conforms
Loss on drying: ≤0.5% 0.21%
Residue on Ignition: ≤0.1％ 0.04%
Heavy Metals: ≤10ppm <10ppm
Assay: 98--102.0% 99.6%
Conclusion: The Specification conforms to the rule of USP26.
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ZXFPC0030
Adenosine
CAS Number: 58-61-7
Adenosine
Appearance: White or almost white crystalline powder
Quality Index Standard Results
Identification: Rule of USP26 Conforms
Loss on drying: ≤0.5％ 0.08%
Residue on Ignition: ≤0.1％ 0.03%
Melting point: 233--238℃ 233.9-235.2℃
Specific rotation: -68.0°-- -72.0° -68.6°
Heavy Metals: ≤10ppm <10ppm
Acidity or alkalinity: Rule of USP26 Conforms
Chloride: ≤0.007% Conforms
Related Substance: Rule of USP26 Conforms
Assay(HPLC): ≥99% 99.77%
Conclusion: The Specification conforms to the rule of USP26.
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ZXFPC0039
Alendronate Sodium
CAS Number: 645-05-6
Alendronate Sodium
Appearance: White crystalline powder
Quality Index Standard Results
Identification: IR complies IR Complies
PH: 4.2-4.6 4.3
Related substances:
Total Impurities: ≤0.5％ 0.3%
Individuals impurity: ≤0.1％ 0.03%
Chloride: ≤0.01％ Conforms
Loss on drying: 16.0-17.5％ 16.5%
Heavy metals: ≤10ppm <10ppm
Assay: 98.0-101.0% 99.5%
Conclusion: The Specification conforms to the rule of Enterprise Standard.
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ZXFPC0039
Alendronic Acid
Alendronic Acid
Appearance: White or off-white crystalline powder
Quality Index Standard Results
Identification: Rule of ES Conforms
Melting point: 230--235℃ 230.7-231.4℃
Loss on drying: ≤7.0% 6.94%
Heavy Metals: ≤20ppm <20ppm
Assay: 98--102.0% 99.1%
Conclusion: The Specification conforms to the rule of Enterprise
Standard.
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ZXFPC0045
Altretamine
CAS Number: 645-05-6
Altretamine
Appearance: White or off-white crystalline powder
Quality Index Standard Results
Identification: Rule of CP2000 Conforms
Melting point: 170--174℃ Conforms
Chloride: ≤0.01% Conforms
Loss on drying: ≤0.5% 0.10%
Residue on Ignition: ≤0.1％ 0.02%
Assay: 98.0-102.0% 99.5%
Conclusion: The Specification conforms to the rule of CP2005.
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ZXFPC0049
Amisulpride
CAS Number: 71675-85-9
Amisulpride
Appearance: White or almost white crystalline powder
Quality Index Standard Results
Identification: Rule of ES Conforms
Melting point: 120--126℃ 122.5-124.6℃
Loss on drying: ≤0.5% 0.03%
Assay: >98.0% 98.5%
Conclusion: The Specification conforms to the rule of Enterprise
Standard.
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ZXFPC0051
Amlodipine Besylate / Maleate
CAS Number: 88150-42-9
Amlodipine Besylate
Appearance: White or almost white crystalline powder
Quality Index Standard Results
Identification: Rule of ES Conforms
Specific rotation: -0.1?--+0.1? +0?
Related substances: ≤0.3% Conforms
Loss on drying: ≤0.5% 0.29%
Sulphated Ash: ≤0.2% 0.026%
Assay: 99.0---101.0% 99.5%
Conclusion: The Specification conforms to the rule of Enterprise Standard.
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ZXFPC0053
Amphotericin B
CAS Number: 1397-89-3
Amphotericin B
Appearance: Orange yellow powder
Quality Index Standard Results
Identification: Rule of USP25 Conforms
Limit of Amphotericin A: Rule of USP25 Conforms
Loss on drying: ≤5.0％ 3.3%
Residue on ignition: ≤0.5% 0.1%
Assay: ≥750ug/mg 807ug/mg
Conclusion: The Specification conforms to the rule of USP25.
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ZXFPC0068
Atorvastatin Calcium
CAS Number: 134523-03-8
Atorvastatin Calcium
Appearance: White or almost white crystalline powder
Quality Index Standard Results
Identification: Rule of ES Conforms
Solubility: Rule of ES Conforms
Water: 3.5-5.5% 4.9%
Ca: 2.8-3.8％ 3.4%
Heavy Metals: ≤10ug/g Conforms
Total impurities: ≤2.0% 0.9%
Individual impurity: ≤0.5% 0.41%
Assay: 98--102.0% 99.0%
Conclusion: The Specification conforms to the rule of Enterprise Standard.
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ZXFPC0071
Azatadine Maleate
CAS Number: 3964-81-6
Azatadine Maleate
Appearance: White or off-white crystalline powder
Quality Index Standard Results
Identification: IR and UV Conforms
Loss on drying: ≤1.0% 0.05%
Residue on Ignition: ≤0.1％ 0.06%
Chromatograqhic Purity: Rule of USP25 Conforms
Assay: 98--102.0% 99.8%
Conclusion: The Specification conforms to the rule of USP25.
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ZXFPC0073
Azelnidipine
CAS Number: 123524-52-7
Azelnidipine
Appearance: Yellowish to yellow crystals
Quality Index Standard Results
Identification: Rule of ES Conforms
Melting point: 120--126℃ 120.5-122.0℃
Specific rotation: +17.0°-- +20.0° +19.5°
Related Substance:
Any individual impurity: ≤0.5% 0.13%
Total impurities: ≤1.0% 0.32%
Residue on Ignition: ≤0.2％ 0.07%
Heavy Metals: ≤20ppm <20ppm
Loss on drying: ≤1.0% 0.2%
Assay: >98.5% 99.1%
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ZXFPC0074
Azithromycin /Azithromycin Dihydrate
CAS Number: 83905-01-5
Azithromycin Dihydrate
Appearance: White crystalline powder
Quality Index Standard Results
Identification: Rule of USP26 Conforms
Specific rotation: -45°-- -49° -47.3°
Crystallinity and Solubility: Rule of USP26 Conforms
PH: 9.0---11.0 9.96
Water: 4.0-5.0% 4.6%
Acetone: ≤0.5％ 0.27%
Residue on ignition: ≤0.3％ 0.06%
Heavy metals: ≤25ppm <25ppm
Assay: 945---1030μg/mg 975μg/mg
Conclusion: The Specification conforms to the rule of USP26.
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ZXFPC0080
Betacarotene
CAS Number: 7235-40-7
Betacarotene
Appearance: Amaranth or red crystalline powder
Quality Index Standard Results
Identification: Rule of ES/USP Conforms
Melting point: 176--182℃ Conforms
Loss on drying: ≤0.2% 0.1%
Heavy Metals: ≤10ppm <10ppm
Arsenic: ≤3ppm <3ppm
Sulphated Ashes: ≤0.2％ 0.1%
Related Substance : Rule of ES/USP Conforms
Assay: >98.0% 98.5%
Conclusion: The Specification conforms to the rule of ES/USP.
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ZXFPC0083
Betulinic Acid
CAS Number: 472-15-1
Betulinic Acid
Appearance: White powder
Quality Index Standard Results
Identification: Rule of ES Conforms
Melting point: about 270℃ Conforms
Loss on drying: ≤1.5% 1.2%
Assay: >90.0% 92.0%
Conclusion: The Specification conforms to the rule of Enterprise
Standard.
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ZXFPC0095
Buflomedil HCl
CAS Number: 35543-24-9 / Base 55837-25-7
Buflomedil HCl
Appearance: White or off-white crystalline powder
Quality Index Standard Results
Identification: Rule of CP2000 Conforms
Solubility: Rule of CP2000 Conforms
Melting point: 194--198℃ 194-195℃
PH: 4.5-7.0 6.25
Related Substance: ≤1.0％ 0.04%
Loss on drying: ≤0.5% 0.42%
Residue on Ignition: ≤0.1％ 0.08%
Heavy metals: ≤10ppm <10ppm
Assay: >98.5% 99.6%
Conclusion: The Specification conforms to the rule of CP2000.
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ZXFPC0101
Calcium Levofolinate
CAS Number: 80433-71-2 / 1492-18-8
Calcium Levofolinate
Appearance: White or yellowish crystalline powder
Quality Index Standard Results
Identification: Rule of ES Conforms
Solubility: Rule of ES Conforms
Specific rotation: -12?-- -15? -13.6?
Water: 10--17% 16.8%
PH: 6.5-8.5 7.98
Heavy Metals: ≤50ppm <50ppm
Related Substance: ≤2.0% 0.88%
10-Formylfolic Acid: ≤0.8％ 0.12%
Ethanol: ≤0.5％ Conforms
(R)-Isomer: ≤0.5％ 0.28%
Calcium: 7.54-8.14% 8.04%
Assay: >98.0% 99.05%
Conclusion: The Specification conforms to the rule of Enterprise
Standard.
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ZXFPC0102
Camptothecinum
CAS Number: 7689-03-4
Camptothecin
Appearance: Yellow powder
Quality Index Standard Results
Identification: Positive Positive
Melting point: 259－263℃ 261℃
Loss on drying: ≤0.5% 0.34%
Total plate count: ≤1000cfu/g 200cfu/g
Mould: ≤100cfu/g 10cfu/g
E.Coli: NEG NEG
Salmosella: NEG NEG
Assay: 98--102.0% 99.3%
Conclusion: The Specification conforms to the rule of Enterprise Standard.
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ZXFPC0103
Candesartan Cilexetil
CAS Number: 145040-37-5
Candesartan
Appearance: White or almost white crystalline powder
Quality Index Standard Results
Identification: Rule of ES Conforms
Loss on drying: ≤0.4% 0.3%
Residue on ignition: ≤0.1% 0.29%
Heavy metals: ≤20ppm <20ppm
Assay: 98.0---102.0% 98.58%
Conclusion: The Specification conforms to the rule of Enterprise Standard.
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ZXFPC0105
Capecitabine
CAS Number: 154361-50-9
Capecitabine
Appearance: White or almost white crystalline powder
Quality Index Standard Results
Identification: Rule of ES Conforms
Loss on drying: ≤1.0% 0.6%
Melting point: 115--120℃ 117.5-118.5℃
Residue Solvent: ≤1.0% 0.05%
Arsenium: ≤2ppm <2ppm
Residue on ignition: ≤0.1% 0.09%
Specific rotation: +90?--+110? +98?
Related substances: Rule of ES Conforms
Heavy metals: ≤20ppm <20ppm
HPLC Assay: 98.5 % Min 99.53%
UV Assay: 98.5---101.5% 99.1%
Conclusion: The Specification conforms to the rule of Enterprise Standard.
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ZXFPC0107
Capsaicin
CAS Number: 404-86-4
Capsaicin
Identification Should Comply Complies
Melting range 57℃ to 66℃ 58℃ to 63℃
Loss on drying NMT 1.0% 0.67%
Residue of scorched NMT 1.0% 0.26%
Content of capsaicin NLT 55.0% 61.61%
Capsaicin and Dihyrocapsaicin NLT 75.0% 86.85%
Other capsaicinoids NMT 15.0% 5.83%
Total capsaicinoids 90.0% to 110.0% 92.67%
Conclusion: The Specification conforms to the rule of USP25.
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ZXFPC0112
Carmustine
CAS Number: 154-93-8
CARMUSTINE
Appearance: Yellowish crystalline powder
Quality Index Standard Results
Identification: Rule of CP95 Conforms
Melting point: 30---32℃ 30--32℃
Loss on drying: ≤1.0% 0.28%
Residue on Ignition: ≤0.1％ 0.06%
Assay: 97--102.0% 98.9%
Conclusion: The Specification conforms to the rule of CP95.
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ZXFPC0113
Carvedilol
CAS Number: 72956-09-3
Carvedilol
Appearance: White or off white crystalline powder
Quality Index Standard Results
Identification: IR, HPLC Conforms
Solubility: Rule of EP4 Conforms
Melting Point: 113--117℃ 114-115.5℃
Heavy metals: ≤0.001% <0.001%
Sulphated Ash: ≤0.10％ 0.05%
Loss on drying: ≤0.5％ 0.32%
Related substance Single: ≤0.2％ 0.13%
(HPLC) Impurities: Total: ≤0.5％ 0.36%
Assay: 99.0-101.0% 99.55%
Microbiological Tests
Total bacteria <1000cfu/g Conforms
Total fungus <100cfu/g Conforms
Coliforms Negative Conforms
Salmonella typhii Negative Conforms
Staphylococcus aureus Negative Conforms
Escherichia coli Negative Conforms
Pseudomona aeruginosa Negative Conforms
Conclusion: The Specification conforms to the EP4rd.
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ZXFPC0115
Cefixime
CAS Number: 79350-37-1
Cefixime
Appearance: White or yellow crystalline powder
Quality Index Standard Results
Identification: Positive Positive
Specific rotation: +75?-- +88? +82?
Crystallinity: Rule of USP27 Conforms
PH: 2.6-4.1 3.5
Water: 9.0-12.0% 10.7%
Related Substance:
Any individual impurity: ≤1.0% Conforms
Total impurities: ≤2.0% 0.99%
Assay (dried basis, HPLC): 95--103.0% 97.0%
Conclusion: The Specification conforms to the rule of Enterprise Standard.
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ZXFPC0121
Cefprozil
CAS Number: 38821-53-3
Cefprozil
Appearance: Pale yellow or yellow crystalline powder
Quality Index Standard Results
Identification: Rule of USP27 Conforms
PH: 3.5-6.5 4.65
Water (K. F.): 3.5-6.5％ 5.05%
Residue on Ignition: ≤0.1％ 0.042%
Heavy Metals: ≤20ppm <20ppm
Residual Solvents by GC: Rule of USP27 Conforms
Cefprozil E-Isomer Ration: 0.06-0.11% 0.098%
Related Substance (HPLC):
Any individual impurity: ≤0.7% 0.12%
Total impurities: ≤2.0% 0.22%
Assay: 900-1050ug/mg 1009.80ug/mg
Conclusion: The Specification conforms to the rule of USP27/ES.
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ZXFPC0123
Ceftazidime
CAS Number: 72558-82-8
Ceftazidime
Appearance: White or almost white crystalline powder
Quality Index Standard Results
Identification: Rule of CP2000 Conforms
Solubility: Rule of CP2000 Conforms
PH: 3.0-4.0 3.7
Pyridine: ≤0.12% 0.02%
Loss on drying: 13.0-15.0% 14.1%
Residue on Ignition: ≤0.2％ 0.12%
Heavy Metals: ≤20ppm <20ppm
Assay: 98--102.0% 99.23%
Conclusion: The Specification conforms to the rule of CP2000.
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ZXFPC0130
Centella Asiatica Extract
Centella Asiatica Extract (Centella Selected Triterpenes)
Appearance: White to creamy powder
Quality Index Standard Results
TCL: Rule of ES Conforms
Loss on drying: ≤3％ 1.55%
Heavy metals: ≤10ppm <10ppm
Sulphate Ash: ≤1.0％ 0.62%
Assay (by HPLC):
Asiaticoside 36--44% 38.101%
Madecassic & Asiatic Acid 54-64% 56.401%
Total: ≥90% 94.502%
Granule Size: 98% Pass 100 mesh Conforms
Total bacteria count ≤1000/gm 146/gm
Yeast/moulds ≤100/gm Conforms
E-Coli Negative Negative
Pseudomonas aeruginosa Negative Negative
Staphylococcus aureus Negative Negative
Conclusion: The Specification conforms to the rule of Enterprise Standard.
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ZXFPC0132
Ceramide E
Ceramide E
Appearance: Off-white powder
Quality Index Standard Results
Melting range: 70--74℃ 72.3-73.1℃
Peak Value: 3300 Conforms
1650 Conforms
1560 Conforms
1470 Conforms
1125 Conforms
1065 Conforms
730 Conforms
Conclusion: The Specification conforms to the rule of Enterprise Standard.
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ZXFPC0135
Chlorcyclizine HCl
CAS Number: 1620-21-9
Chlorcyclizine HCl
Appearance: White crystalline powder
Quality Index Standard Results
Identification: Positive Positive
PH: 4.5---6.0 5.1
Loss on drying: ≤2.0％ 1.1%
Residue on ignition: ≤0.10％ 0.08%
Related substance: Enterprise Standard Conforms
Assay: 97.0-101.0% 98.2%
Conclusion: The Specification conforms to the rule of Enterprise Standard.
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ZXFPC0143
Cisplatin
CAS Number: 15663-27-1
Cisplatin
Appearance: Light yellow powder
Quality Index Standard Results
Identification: Rule of USP26 Conforms
Trichloroammine platinate: ≤1.0% 0.13%
Water Content: ≤1.0% 0.21%
Platinum Content: 64.42-65.22% 64.95%
Transplatin: ≤2.0% 0.0%
UV purity ratio: ≥4.5% 4.7%
Assay (HPLC): 98--102% 99.2%
Conclusion: The Specification conforms to the rule of USP26.
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ZXFPC0150
Coenzyme A
CAS Number: 85-61-0
Coenzyme A (Free Acid)
Appearance: Almost white or Slight yellowish powder
Quality Index Standard Results
Identification: Rule of ES Conforms
Appearance of Solution: Clear, slightly opalescent Conforms
Loss on drying (K.F.): ≤6.0% 5.4%
Assay (ABS 257nm 0.01mol/L HCL PH2ε=14.600, Spcetrophotom): >85.0%
93.0%
Purity (From HPLC 2-Propanol / NH3 / H2O = 55 : 4 : 35)
CoA, Red >88.0% 91.3%
CoA, Oxid ≤5.0% 3.3%
Dephospho-CoA ≤6.0% 4.7%
Conclusion: The Specification conforms to the rule of Enterprise
Standard.
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ZXFPC0152
Cyanocobalamin /Vitamin B12
CAS Number: 68-19-9
Cyanocobalamin (Vitamin B12)
Appearance: Dark red crystalline powder
Quality Index Standard Results
Identification: Positive Positive
Loss on drying: ≤12％ 2.87%
Pseudo Cyanocobalamin: Rule of USP24 Conforms
Pyrogen: Rule of USP24 Conforms
Assay: 96.0-100.5% 98.44%
Conclusion: The Specification conforms to the rule of USP24.
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ZXFPC0154
Cyclophosphamide
CAS Number: 50-18-0
Cyclophosphamide
Appearance: A White crystalline powder
Quality Index Standard Results
Identification: Rule of USP24 Conforms
Acidity PH: 3.9-7.1 5.6
Clarity and Color solution: Clear Conforms
Chloride: ≤180ppm Conforms
Heavy metals: ≤0.001% Conforms
Water: 5.7-6.8％ 6.6%
Assay: 97.0-103.0% 99.96%
Conclusion: The Specification conforms to the rule of USP24.
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ZXFPC0155
Cyclosporin D
Cyclosporin D
Appearance: Colorless Prisms
Quality Index Standard Results
Identification: Rule of ES Conforms
Melting point: 146--151℃ 146--150℃
Heavy Metals: ≤0.02% <0.02%
Total impurities: ≤5.0% 3.6%
Water: ≤3.0% <3.0%
Assay (by HPLC): >95.0% 96.4%
Conclusion: The Specification conforms to the rule of Enterprise Standard.
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ZXFPC0172
Didanosine(DDI)
CAS Number: 69655-05-6
Didanosine
Appearance: White crystalline powder
Quality Index Standard Results
Specific rotation: -24°-- -28° -26.5°
Loss on drying: ≤0.5％ 0.35%
Residue on ignition: ≤0.2％ 0.02%
Total impurities: ≤1％ 0.85%
Heavy metals: ≤10ppm <10ppm
Assay: ≥99.0% 99.15%
Conclusion: The specification conforms to the rule of Enterprise Standard.
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ZXFPC0175
Dimercaptopropanesulfonic sodium
CAS Number: 74-61-3
Dimercaptopropanesulfonic Sodium
Appearance: White or almost white crystalline powder
Quality Index Standard Results
Iron: ≤50ppm <50ppm
Loss on drying: ≤0.5% 0.30%
Sulfated Ash: 32.5-34.5% 33.3%
Heavy Metals: ≤10ppm <10ppm
Assay: 97--102.0% 98.2%
Conclusion: The Specification conforms to the rule of Enterprise Standard.
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ZXFPC0177
Dobutamine HCl
CAS Number: 34368-04-2
Dobutamine HCL
Appearance: White or off-white crystalline powder
Quality Index Standard Results
Identification: USP24 Conforms
Colour of solution: ≤0.04 <0.04
Loss on drying: ≤1.0％ 0.29%
Residue on ignition: ≤0.20％ 0.03%
Heavy metals: ≤0.003% <0.002%
Single impurities: ≤0.50％ 0.09%
Total impurities: ≤1.00％ 0.48%
Assay: 98.0％--102.0％ 99.63%
Conclusion: The Specification conforms to the rule of USP24.
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ZXFPC0178
Docetaxel Anhydrous / Trihydrate
CAS Number: 114977-28-5
Docetaxel Trihydrate
Appearance: White or almost white crystalline powder
Quality Index Standard Results
Identification: IR Conforms
Water: 4.4-8.2% 6.2%
Specific rotation: -35?-- -42? -40?
Related substances: ≤1.0% 0.31%
Dichloromethane: ≤0.06% 0.005%
Methanol: ≤0.5% 0.04%
Assay: ≥98.5% 99.6%
Conclusion: The Specification conforms to the rule of Enterprise Standard.
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ZXFPC0183
Doxazosin Mesylate
CAS Number: 77883-43-3 / Base 74191-85-8
Doxazosin Mesylate
Appearance: White or off-white crystalline powder
Quality Index Standard Results
Identification: Positive Conforms
PH: 3.5-4.5 3.9
Chlorides: ≤0.015% Conforms
Related Substance : ≤0.5% Conforms
Loss on drying: ≤1.0% 0.3%
Residue on Ignition: ≤0.1％ 0.04%
Heavy Metals: ≤10ppm <10ppm
Assay: 98--102.0% 99.9%
Conclusion: The Specification conforms to the rule of Enterprise
Standard.
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ZXFPC0186
Doxycycline Hyclate / Monohydrate
CAS Number: 24390-14-5 / Mono 17086-28-1
Doxycycline Monohydrate
Appearance: A yellow crystalline powder
Quality Index Standard Results
Identification: Rule of EP4 Conforms
Acidity: 5.0-6.5 5.4
Specific rotation: -113?-- -130? -117?
Light absorption: 325--363 352
Light-absorbing impurities: ≤0.07% 0.01%
Methacyline HCl: ≤2.0％ 0.08%
6-epidoxcycline HCl: ≤2.0％ 0.85%
Other impurities: ≤0.5% 0.41%
Heavy Metals: ≤50ppm <50ppm
Water: 3.6-4.6% 3.8%
Sulphated ash ≤0.4% 0.1%
Assay: 95--102.0% 98.5%
Conclusion: The Specification conforms to the rule of EP4.
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ZXFPC0187
Ebastine
CAS Number: 90729-43-4
Ebastine Base
Appearance: White or almost white crystalline powder
Quality Index Standard Results
Identification: Rule of ES Conforms
Melting point: 82--84℃ 82.3-83.6℃
Loss on drying: ≤0.5% 0.16%
Sulphated Ash: ≤0.1% 0.023%
Heavy metals: ≤10ppm <10ppm
Assay: 98.0---102.0% 99.73%
Conclusion: The Specification conforms to the rule of Enterprise Standard.
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ZXFPC0199
Epinastine HCl
CAS Number: 80012-43-7
Epinastine Base
Appearance: White crystalline powder
Quality Index Standard Results
Identification: Rule of ES Conforms
Loss on drying: ≤0.5% 0.1%
Residue on Ignition: ≤0.1％ 0.07%
Heavy Metals: ≤20ppm <20ppm
Water content (K. F.): ≤1.0% 0.08%
Related Substance: ≤0.5% 0.2%
Assay: 98.5-101.0% 99.5%
Conclusion: The Specification conforms to the rule of Enterprise Standard.
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ZXFPC0208
Etidronate Disodium
CAS Number: 7414-83-7
Etidronate Disodium
Appearance: White powder, Odorless
Quality Index Standard Results
Identification: Positive Positive
PH: 4.2-5.2 4.7
Phosphite: ≤1.0％ 0.01%
Loss on drying: ≤5.0％ 4.3%
Heavy metals: ≤20ppm <20ppm
Assay: 97.0-101.0% 98.0%
Conclusion: The Specification conforms to the rule of CP2000 / ES.
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ZXFPC0210
Etoposide
CAS Number: 33419-42-0
Etoposide
Appearance: Fine white to off white crystalline powder
Quality Index Standard Results
Identification: IR and HPLC Conforms
Specific rotation: -110°-- -118° -115.3°
Solubility: Rule of USP24 Conforms
Water: ≤6.0％ 1.5%
Residue on ignition: ≤0.10％ 0.02%
Heavy metals: ≤20ppm <20ppm
Related compounds:
Lignan P ≤0.5％ <0.5%
Picroetoposide ≤1.0％ <1.0%
Total ≤2.0％ <2.0%
Assay: 95.0-105.0% 98.5%
Conclusion: The Specification conforms to the rule of USP24.
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ZXFPC0216
Fenofibrate
CAS Number: 49562-28-9
Fenofibrate
Appearance: White or yellowish crystalline powder
Quality Index Standard Results
Identification: Rule of BP2000 Conforms
Melting point: 79--82℃ 80.5-81.5℃
Appearance of Solution: <GY6 Conforms
Acidity: Rule of BP2000 Conforms
Related Substance (HPLC): Rule of BP2000 Conforms
Halogens: ≤100ppm <100ppm
Sulphates: ≤100ppm <100ppm
Heavy Metals: ≤10ppm <10ppm
Loss on drying: ≤0.5% 0.1%
Sulphated Ash: ≤0.1％ 0.06%
Assay: 98.5--101.0% 99.9%
Conclusion: The Specification conforms to the rule of BP2000.
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ZXFPC0217
Fenofibric Acid
CAS Number: 42017-89-0
Fenofibric Acid
Appearance: White or almost white crystalline powder
Quality Index Standard Results
Identification: Rule of ES Conforms
Melting point: 176--179℃ 177--178℃
Loss on drying: ≤0.5% 0.38%
Residue on Ignition: ≤0.3％ <0.3%
Assay: ≥98.0% 98.5%
Conclusion: The Specification conforms to the rule of Enterprise Standard.
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ZXFPC0220
Fexofenadine Hydrochloride
CAS Number: 153439-40-8
Fexofenadine HCl
Appearance: White to off white crystalline powder
Quality Index Standard Results
Identification: Rule of ES Conforms
Solubility: Soluble in Methanol Conforms
Melting point: 192--200℃ 194-196℃
Colour absorbance: ≤0.1 0.02
Sulphate ash: ≤0.2％ 0.09%
Loss on drying: ≤0.5% 0.11%
Related substances: ≤1.0％ 0.3%
Organic volatile impurities: ≤100ppm Not detected
Related Solvents: Rule of ES Conforms
Assay: 98.5-101.0% 99.4%
Conclusion: The specification conforms to the rule of Enterprise Standard.
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ZXFPC0226
Fluocinolone Acetonide
CAS Number: 67-73-2
Fluocinolone Acetonide
Appearance: White or off-white crystalline powder
Quality Index Standard Results
Identification: Rule of BP93 Positive
Specific rotation: +92°-- +96° +94.4°
Loss on drying: ≤1.0％ 0.14%
Related substances: ≤2％ (One spot) Conforms
Light Absorption: 345---375 354.9
Powder size: Micronized Conforms
Assay: 96-104.0% 98.7%
Conclusion: The Specification conforms to the rule of BP93.
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ZXFPC0227
Fluocinonide
CAS Number: 356-12-7
Fluocinonide
Appearance: White or almost white crystalline powder
Quality Index Standard Results
Identification: Rule of CP2000 Conforms
Specific rotation: +80°-- +88° +85°
Loss on drying: ≤0.5% 0.21%
FL: >7.0% 7.1%
Steroids: Rule of CP2000 Conforms
Residue on Ignition: ≤0.1％ 0.04%
As: Rule of CP2000 Conforms
Assay: 97.0-103.0% 97.7%
Conclusion: The Specification conforms to the rule of CP2000.
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ZXFPC0237
Galanthamine Hydrobromide
CAS Number: Base 357-70-0
Galanthamine Hydrobromide
Appearance: White or off-white crystalline powder, bitter
Quality Index Standard Results
Solubility: Rule of CP2000/USP24 Conforms
PH: 4.5-6.5 4.7
Clarity of solution: Clear Conforms
Specific rotation: -90?-- -100? -95.8?
Melting point: 244--- 249℃ 247℃
Loss on drying: ≤1.0％ 0.16%
Specific absorbance(289nm): 79.6-86.2 81.5
Heavy metals: ≤20ppm <20ppm
Sulphated Ash: ≤1.0mg/g 0.3mg/g
Other alkaloids: Rule of CP2000/USP24 Conforms
Assay: ≥98.0% 98.3%
Conclusion: The Specification conforms to the rule of CP2000/USP24.
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ZXFPC0238
Ganciclovir
CAS Number: 82410-32-0
Ganciclovir
Appearance: White crystalline powder
Quality Index Standard Results
Identification: Rule of ES Conforms
Absorption Coefficient: 516--548 526
Related substances(HPLC): ≤1.0% <1.0%
Limit for guanine: ≤0.7% 0.6%
Loss on drying: ≤6.0% 1.5%
Residue on ignition: ≤0.1% 0.04%
Heavy metals: ≤10ppm <10ppm
Assay: 98.0---102.0% 99.2%
Conclusion: The Specification conforms to the rule of Enterprise Standard.
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ZXFPC0239
Gatifloxacin HCl
CAS Number: 160738-57-8
Gatifloxacin
Appearance: Whitish or Yellowish crystalline powder
Quality Index Standard Results
Identification: Rule of ES Conforms
Impurity: ≤1.0％ 0.24%
Fluorine: ≥4.6% >4.6%
Water: 4-8% 6.02%
Residue on Ignition: ≤0.2％ 0.06%
Heavy metals: ≤0.002% <0.002%
Clarity (650nm): ≥95.0% 99.3%
Colour index: ≤0.2A 0.09A
Assay: ≥99.0% 99.76%
Conclusion: The Specification conforms to the rule of Enterprise Standard.
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ZXFPC0243
Gentamycin Sulphate
CAS Number: 1405-41-0
Gentamicin Sulfate
Appearance: White or almost white crystalline powder
Quality Index Standard Results
Identification: Rule of BP2000 Conforms
Appearance of solution: Rule of BP2000 Conforms
PH: 3.5---4.5 4.3
Specific optical rotation: +107?--+121? +119?
Methanol: Not more than 1.0% Conforms
Composition: C1 : 25.0-50.0% 28.09%
C1a: 10.0-35.0% 25.77%
C2a+ C2: 25.0-55.0% 46.14%
Water: Not more than 15.0% 8.9%
Sulphate Ash: Not more than 1.0% 0.03%
Sulphate: 32.0-35.0% 33.8%
Sterility: Rule of BP2000 Conforms
Bacterial endotoxins: Not more than 0.71 IUE./mg Conforms
Assay: Not less than 590 I.U./mg
(Anhydrous substance) 649 I.U./mg
(Hydrous substance) 591 I.U./mg
Conclusion: The Specification conforms to the rule of BP2000/EPIV.
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ZXFPC0246
Glabridin
Glabridin
Plant Name: Radix Glycyrrhizae glabrae
Quality Index Standard Results
Assay(BYHPLC)Content >20.0% 21.0%
Identification Conforms Conforms
Appearance Powder Conforms
Color Tan to red brown Conforms
Taste Characteristic Conforms
Particle size 100%pass100mesh Conforms
Solubility Soluble in Ethanol Conforms
Water content <5.0% 3.9%
Residue on ignition <0.5% 0.3%
Arsenium salt <2ppm Conforms
Heavy metal < 20ppm Conforms
Conclusion: The Specification conforms to the rule of Enterprise
Standard.
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ZXFPC0248
Gliclazide
CAS Number: 21187-98-4
Gliclazide
Appearance: White or almost white powder
Quality Index Standard Results
Identification: Rule of BP98 Conforms
Heavy metals: ≤10ppm <10ppm
3-Nitroso-3-azabicyclo[3.3.0]octane: ≤2ppm <2ppm
Related substances:
1-(3-abicyclo[3.3.0]oct-3-yl)-3-o-tolylsulphonylurea:≤0.1％ 0.03%
Other single impurity (max): ≤0.1％ 0.02%
Other total impurities (max): ≤0.2％ 0.08%
Loss on drying: ≤0.25％ 0.09%
Sulphated ash: ≤0.1％ 0.04%
Assay: 99.0-101.0% 99.66%
Conclusion: The Specification conforms to the rule of BP98.
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ZXFPC0249
Glimepiride
CAS Number: 93479-97-1
Glimepiride
Appearance: White crystalline powder
Quality Index Standard Results
Identification: Rule of ES Conforms
Melting point: 205--207℃ 206℃
Loss on drying: ≤0.5％ 0.1%
Sulphate: ≤0.04％ 0.02%
Chloride: ≤0.015％ 0.01%
Residue on ignition: ≤0.1％ 0.06%
Heavy metals: ≤10ppm <10ppm
Total impurities: ≤1.0％ 0.8%
Related substances: ≤1.0％ 0.2%
Assay: ≥99.0% 99.3%
Conclusion: The specification conforms to the rule of Enterprise Standard.
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ZXFPC0253
Gotu kola P.E.
Gotu Kola P.E.
Appearance: Light-brown fine powder Origin: Centella Asiatica
Quality Index Standard Results
Loss on drying: ≤5.0% 1.88%
Heavy Metals: ≤10ppm <10ppm
Total Ash: ≤2.0％ 1.45%
Acid insoluble ash: ≤1.0％ 0.57%
Mesh Size: 98% pass 100 Mesh Conforms
Microbiology Control:
Total bacteria Count: ≤1000/g 0.3/g
Yeast & Moulds: ≤100/g Conforms
E.Coli: Negative Conforms
Pseudomonas : Negative Conforms
Staphylococcus: Negative Conforms
Assay (Total triterpenes): >20% 20.5%
Conclusion: The Specification conforms to the rule of Enterprise Standard.
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ZXFPC0254
Granisetron Base
CAS Number: 107007-99-8
Granisetron (Base)
Appearance: White or pale yellow powder, odorless
Quality Index Standard Results
Identification: HPLC. UV. Conforms
Related substance: ≤1.0% 0.2%
Dichloromethane: ≤0.06% Conforms
Trichloromethane: ≤0.006% Conforms
Toluene: ≤0.089% Conforms
Loss on drying: ≤1.0% 0.20%
Sulphated Ash: ≤0.1% 0.04%
Heavy metals: ≤20ppm <20ppm
Assay(HPLC): 98.0---102.0% 99.0%
Conclusion: The Specification conforms to the rule of Enterprise Standard.
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ZXFPC0255
Granisetron Hydrochloride
CAS Number: 107007-99-8
Granisetron HCl
Appearance: White or pale yellow crystalline powder
Quality Index Standard Results
Identification: Rule of ES Conforms
Clarity of solution: Rule of ES Conforms
PH: 4.0-6.5 4.8
Related substances: ≤1.0% 0.1%
Dichloromethane: ≤0.06% Conforms
Trichloromethane: ≤0.006% Conforms
Toluene: ≤0.089% Conforms
Loss on drying: ≤1.0% 0.29%
Residue on ignition: ≤0.1% Conforms
Sulphated Ash: ≤0.1% 0.05%
Heavy metals: ≤20ppm <20ppm
Assay: 98.0---102.0% 99.7%
Conclusion: The Specification conforms to the rule of Enterprise Standard.
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ZXFPC0258
Halofuginone
CAS Number: 55837-20-2
Halofuginone
Appearance: Brown-yellow powder
Quality Index Standard Results
Identification: Rule of ES Conforms
Water: ≤5.0% 4.0%
Ash: ≤5.0％ 3.0%
Others: Rule of ES Conforms
Assay: >5.0% 5.1%
Conclusion: The Specification conforms to the rule of Enterprise
Standard.
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ZXFPC0265
Hyaluronidase
CAS Number: 9001-54-1
Hyaluronidase
Appearance: White or almost yellow powder Origin: testes of sheep
Quality Index Standard Results
Identification: Positive Positive
PH: 4.5-7.5 7.2
Appearance of solution: Clear Clear
Absorption: 260nm ≤0.42% 0.270%
280nm ≤0.60% 0.336%
Tyrosine: ≤0.1% 0.06%
Abnormal Toxin: Rule of CP2000 Conforms
Pyrogens: Rule of CP2000 Conforms
Potency: ≥300IU/mg 915IU/mg
Conclusion: The Specification conforms to the rule of CP2000.
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ZXFPC0267
Hydroxocobalamin / Vitamin B12
CAS Number: 13422-51-0
Hydroxocobalamin
Appearance: Dark Red crystalline powder
Quality Index Standard Results
Identification: Rule of USP27 Conforms
Cyanocobalamin: ≤5.0% ----
PH: 8.0-10.0 9.55
Loss on drying: 14.0-18.0% 17.2%
Assay: 95.0-102.0% 95.8%
Conclusion: The Specification conforms to the rule of USP27.
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ZXFPC0273
Idebenone
CAS Number: 58186-27-9
Idebenone
Appearance: Yellow-range and odorless crystalline powder
Quality Index Standard Results
Solubility: Enterprise standard Conforms
E 1%: 458--486 Conforms
Melting point: 52.0--55.0℃ 53-54℃
Loss on drying: ≤0.5％ 0.03%
Residue on ignition: ≤0.10％ 0.05%
Heavy metals: ≤10ppm <10ppm
Impurities: ≤0.8％ 0.78%
Assay: ≥98.5% 99.2%
Conclusion: The Specification conforms to the Enterprise Standard.
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ZXFPC0275
Imatinib mesylate / Gleevec
CAS Number: 220127-57-1
Imatinib Mesylate
Appearance: Off-white crystalline powder
Quality Index Standard Results
Identification: IR Spectrum Conforms
Solubility: Rule of ES Conforms
Melting range: 217.3℃ 216-218℃
Loss on drying: ≤0.5％ 0.14%
Residue on ignition: ≤0.1％ 0.01%
Related substances (Total): ≤2.0％ 0.15%
Residual Solvents(Methanol): ≤3000ppm 2839ppm
Assay (dry basis): 98.0-102.0% 99.28%
Conclusion: The Specification conforms to the rule of Enterprise Standard.
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ZXFPC0283
Irinotecan HCl Trihydrate
CAS Number: 100286-90-6
Irinotecan HCl (trihydrate)
Appearance: Pale yellow powder
Quality Index Standard Results
Identification: A. IR and B. HPLC Conforms
Solubility: Rule of ES Conforms
PH: 3.0-5.0 4.6
Absorbance at 430nm: ≤0.7 Conforms
Water: 7.0-9.0% 8.2%
Chloride: 3.0-5.5％ Conforms
Specific rotation [α]D20: +60°-- +73° +65°
Residue on ignition: ≤0.1％ 0.08%
Heavy metals: ≤20ppm <20ppm
Related Substance (HPLC):
Total: ≤1.0％ 0.48%
Individual: ≤0.5％ 0.17%
Purity by HPLC: >99.0% 99.52%
Assay (HPLC): 99.0-101.0% 99.79%
Conclusion: The Specification conforms to the rule of Enterprise Standard.
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ZXFPC0289
Isotretinoin
CAS Number: 4759-48-2
Isotretinoin
Appearance: Yellow crystalline powder
Quality Index Standard Results
Identification: Rule of USP26 Conforms
Organic volatile impurity: Rule of USP26 Conforms
Loss on drying: ≤0.5％ 0.1%
Residue on ignition: ≤0.1％ 0.03%
Heavy metals: ≤0.002% <0.002%
Limit of Tretinoin: ≤1.0% 0.3%
Assay: 98--102% 99.2%
Conclusion: The Specification conforms to the rule of USP26.
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ZXFPC0291
Itraconazole
CAS Number: 84625-61-6
Itraconazole
Appearance: White or almost white powder
Quality Index Standard Results
Identification: TLC Test Positive Conforms
Melting range: 166--170℃ 167-169℃
Appearance of Solution: Rule of BP2000 Conforms
Loss on drying: ≤0.5％ 0.31%
Sulphated ash: ≤0.10％ 0.06%
Related substances: Rule of BP2000 Conforms
Assay: 98.5-101.5% 99.82%
Conclusion: The Specification conforms to the rule of BP2000.
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ZXFPC0294
Kanamycin Monosulfate A
CAS Number: 59-01-8
KANAMYCIN MONO SULPHATE
Source：Streptomyces kanamycetikus
Appearance: White or almost white crystalline
Quality Index Standard Results
Identification: Positive Positive
Acidity or alkalinity: PH 6.5-8.5 PH 7.8
Specific rotation: +112°-- +123° +122°
Kanamycin B: ≤4.0％ <4.0%
Sulphate: 15.0-17.0 16.3%
Loss on drying: ≤1.5％ 0.44%
Sulphate Ash: ≤0.5％ 0.03%
Potency (Dried substance): ≥750U/mg 773U/mg
Abnormal Toxicity: Rule of BP2000 Conforms
Pyrogens: Rule of BP2000 Conforms
Conclusion: The Specification conforms to the rule of BP2000.
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ZXFPC0296
Ketanserin
CAS Number: 74050-98-9
Ketanserin
Appearance: Light Yellow powder
Quality Index Standard Results
Identification: Rule of ES Conforms
Melting point: 226--235℃ 227--230℃
Loss on drying: ≤0.5％ 0.3%
Assay: ≥97.0% 98.1%
Conclusion: The Specification conforms to the rule of Enterprise Standard.
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ZXFPC0298
Ketotifen Fumarate
CAS Number: 34580-14-8
Ketotifen Fumarate
Appearance: White or off-white crystalline powder
Quality Index Standard Results
Identification: Positive Conforms
Melting point: 191--195℃ 193--194℃
Loss on drying: ≤0.5% 0.20%
Related substances: ≤1.0% Conforms
Sulphated Ash: ≤0.1% 0.02%
Assay: 98.5---101.0% 99.8%
Conclusion: The Specification conforms to the rule of CP2000/EP.
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