Basic Info.
Model NO.
197922-42-2
Molecular Formula
C164h252n44o55s
CAS Registry Number
197922-42-2
Form
Powder
Assay
99%
Color
White
Transport Package
Standard Export Package
Specification
GMP
Trademark
Mesochem
Origin
China
HS Code
2934999090
Production Capacity
10kg/Month
Product Description
Beijing Mesochem Technology Co., Ltd is located in national economic and technological development of Yizhuang, which is a gathering place of world's top 500 enterprises. Devoting to pharmaceutical chemicals, find chemicals, and fundamental chemical material, Mesochem owns independent right of import and export.Based on abundant resources from Beijing various colleges and universities, Mesochem focused on incessant innovation along with research and development of new products.
CERTIFICATE OF ANALYSIS
Product name:Teduglutide
CAS: 19792242-2
BATCH NO.: HF171202 | QUANTITY:75.1kg | ||
MFG. DATE : Dec., 2, 2017 | SPECIFICATION: As required | ||
REP. DATE : Dec.4, 2017 | EXP. DATE : Dec., 2019 | ||
ITEMS | STANDARDS | RESULTS | |
Appearance | White or off-white crystalline powder | Off-white crystalline powder | |
Identification | By IR | Complies | |
RT under chirality should complies | Complies | ||
Chloride: it gives a reaction of chloride | Complies | ||
Water | 3.0%~4.5% | 3.4% | |
Melting Point | 198.0~202.0ºC | 199.8~200.5ºC | |
Residue on Ignition | ≤0.2% | 0.08% | |
Heavy Metals | ≤10ppm | Complies | |
Related Substances | Individual Impurities:≤0.5% | 0.15% | |
Total Impurities:≤1.0% | 0.22% | ||
Residual Solvent | Dichloromethane ≤0.06% | 0.0066% | |
Acetone ≤0.5% | 0.015% | ||
Ethyl acetate ≤0.5% | 0.0013% | ||
E.E | ≥99.0% | 99.6% | |
Assay (on dry basis) | 98.0%~102.0% | 101.2% | |
Conclusion:It complies to prescribed enterprise standard. | |||