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| Срок поставки: | 2 дней |
|---|
Модель: PH-XXG-031
Items |
Acceptance criteria |
Results |
Appearance |
White to off-white crystalline powder |
White crystalline powder |
Solubility |
It is slightly soluble in methanol ,in ethanol(99.5), in acetonitrile , and practically insoluble in water . |
Conforms |
Identification |
A. The IR spectrum is consistent with that obtained with Cilostazol RS |
Consistent with that obtained with Cilostazol RS |
B.The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation ,as obtained in the Assay |
Consistent with that obtained with Standard |
|
Loss on Drying |
≤0.25% |
0.08% |
Residue on Ignition |
≤0.1% |
0.04% |
Chloride |
≤0.018% |
≤0.018% |
Heavy Metals |
≤0.001% |
≤0.001% |
Particle Size |
90%less than 50um |
Conforms |
Related Compounds |
Impurity A≤0.10% |
0.02% |
Impurity B≤0.10% |
0.02% |
|
Impurity C≤0.10% |
0.03% |
|
Any other individual impurity≤0.10% |
See Note 1 |
|
Total impurities≤0.40% |
0.16% |
|
Residual Solvents |
N , N-Dimethy lacetamide ≤0.109% |
Conforms |
Chloroform ≤0.006% |
0.003% |
|
Methanol≤0.3% |
0.100% |
|
Assay by HPLC |
98.0%~102.0%(calculated on dried basis) |
99.8% |
Conclusion |
It complies with the requirement of USP36 |
|
Relative retention time |
Results |
0.5 |
Not-detected |
0.7 |
0.02% |
CATAGORY |
PRODUCTS |
SPECIFICATION |
CAS NO. |
Macrolide |
Azithromycin |
USP38 |
83905-01-5 |
Macrolide |
Azithromycin A |
Enterprise |
/ |
Macrolide |
Erythromycin |
USP36 |
114-07-8 |
Antifungal |
Sirolimus |
USP35 |
53123-88-9 |
Antifungal |
Amphotericin B |
USP32 |
1397-89-3 |
Antifungal |
Terbinafine |
USP32 |
78628-80-5 |
Antifungal |
Sofosbuvir |
Enterprise |
1190307-88-0 |
Antifungal |
Fusidic Acid |
EP7.0 |
6990-06-3 |
Antifungal |
Sodium fusidate |
EP7.0 |
751-94-0 |
Anti-malarial |
Quinine Base |
Enterprise |
130-95-0 |
Anti-malarial |
Quinine HCL |
CP2010 |
60-93-5 |
Anti-malarial |
Quinine sulfate |
BP2010 |
804-63-7 |
Antineoplastic |
Capecitabine |
USP35 |
154361-50-9 |
Antineoplastic |
Paclitaxel |
USP32 |
33069-62-4 |
Nervous system |
Scopolamine hydrolbromide |
Enterprise |
114-49-8 |
Nervous system |
Sodium Tianeptine |
EP8.0 |
30123-17-2 |
Gastrointestinal |
Scopolamine butyllbromide |
BP2010 |
149-64-4 |
Cardiovascular |
Dopamine HCl |
CP2010 |
335081-04-4 |
Hematologic |
Sodium Heparin |
Enterprise |
9041-08-1 |
Memantine |
Latanoprost |
Enterprise |
130209-82-4 |
Memantine |
Bimatoprost |
Enterprise |
155206-00-1 |
Memantine |
Alprostadil |
Enterprise |
745-65-3 |
Cosmetic |
Hyaluronic Acid |
Enterprise |
9067-32-7 |
Cosmetic |
Sodium cromoglycate |
BP2010 |
15826-37-6 |
Cosmetic |
Melatonin |
USP35 |
73-31-4 |
Cosmetic |
Monobenzone |
CP2010 |
103-16-2 |
Cosmetic |
Monobenzone cream |
60% |
/ |
Cosmetic |
Minoxidil |
USP37 |
38304-91-5 |
Other |
Mecobalamin |
JP16 |
13422-55-4 |
Other |
Cyanocobalamin |
EP8.0 |
68-19-9 |
Группа Продуктов : API-интерфейс > Сердечно-сосудистые
