C.The IR spectrum of sample should be identical with that of reference standard;
Complies
D.HPLC-ESI-MS
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.
Complies
Crystallinity
meets the requirements.
Complies
Loss on drying
≤2.0%
0.19%
Heavy metals
≤10 ppm
<10ppm
Water
≤1.0%
0.1%
Sulphated ash
≤0.5%, determined on 1.0 g.
0.009%
Related substances
Unspecified impurities: for each impurity
≤0.10%
<0.10%
Total Impurity
≤0.5%
0.18%
Purity
≥99.0%
99.7%
Assay
99.0%~101.0% (anhydrous substance).
99.8%
Microbiological Analysis
Total plate count
≤1000cfu/g
Complies
Yeast and Moulds
≤100cfu/g
Complies
E. Coli.
Absent
Negative
Salmonella
Absent
Negative
S.aureus
Absent
Negative
Storage
Preserve in well-closed, light-resistant and airtight containers.
Complies
Packaging & Shipping
Company Information
We are a company integrating R&D, production and sales.
Production Ability: The design, research and development of pharmaceutical intermediates is our main business, including more than 330 kinds of pharmaceutical intermediates such as Anti-infectives, Cardiovascular and Cerebrovascular Systems, Digestive System, Snti-tumor, Nervous System, Geriatric Drugs and Gynecological Drugs. At the same time, we have more than 4,000 factories in strategic cooperation with nearly 50,000 chemical products, so we can provide you with one-stop service, which greatly saves customers' procurement costs and time.
Sales Ability:Our sales have more than 5 years of experience in exporting, and are proficient in all processes of business operation which can efficiently fulfill customer needs. We currently exporting more than 70 countries, and the partners who come to the factory to negotiate include Dupont, DSM and so on.
