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What are Reference Chemicals?
USP’s Definition: Reference chemicals are highly characterized specimens of drug substances, excipients, impurities, degradation products, dietary supplements, compendial reagents and performance calibrators.
Reference chemicals are typically used to conduct the followings:
* Identification tests
* Limit tests for impurities or related compounds
* Assays for drug substances and for formulations
* System suitability tests
Characteristics of TCM Reference Chemicals
TCM reference chemicals are extracted and isolated from natural plants and animal products. It’s very difficult to obtain large amount of purified substances because of the complex components in natural plants and animal products, relatively low concentration, and instability of many target substance.
What products do we provide?
We provide more than 400 reference chemicals, most of which are major components of Traditional Chinese Medicine (TCM), used for quality control as dictated by the Chinese Pharmacopoeia.
Quality Assurance
Quality Control: The purity of our reference chemicals is ≥98.0%. All products are verified by the following tests: HPLC, TLC, MS, and NMR. Certification of Analysis, including HPLC and TLC test, contains precise specifications and testing parameters of each lot, and is available upon requests. Custom CoA would also be available and would require some nominal fee for generation.
Certificate of Analysis: We have strict and integrated quality control system to ensure that each lot of products meet the specifications.
Package, Storage and Transportation: We have two standard packaging sizes：10 and 20 mg in air-tight vials that are resistant to ambient light and vapor. Other packaging sizes are available according to customer’s requests. Each vial of product is labeled with detailed information and a unique ID number to ensure the traceability.
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