Generic Product Overview
Our generic API product pipeline focuses on peptide actives for the treament of obesity and diabetis as well as on osteoporosis and other women’s health applications.
Advanced Development
Bivalirudin
Treatment of heparin-induced thrombocytopenia and for the prevention of thrombosis.
Angiotensin II
Angiotensin II is a vasoconstrictor indicated for increasing blood pressure in adults with septic or other distributive shock.
Early Development
Cetrorelix
Subcutaneous injection in assisted reproduction to inhibit premature LH surges.
Elcatonin
Anti-parathyroid agent for remitting or eliminating pain caused by osteoporosis.
Specifications
We have set the following provisional product specifications for our pharmaceutical grade generic peptide API’s, which are controlled by comprehensive GMP testing procedures:
- Appearance: White to Off white powder
- Solubility: clear solution of a pre-specified concentration
- Identity: correct molecular weight, correct amino acid sequence confirmed by MS/MS sequencing, and correct amino acid composition by amino acid analysis
- Peptide purity (HPLC): 95-98% (can be tailored to requirements and stage of the drug development process)
- Related substances (HPLC): 2-5% (can be tailored to requirements and stage of the drug development process)
- Assay (peptide content): >75%
- Counterion content: product dependent (typically acetate)
- Moisture content: <10%
- Mass balance: 95-105%
- Residual Trifluoroacetic acid: <0.25%
- Residual organic solvents: ICH guidelines or dosage dependent
- Bioburden: according to USP or EP guidelines
- Endotoxin: according to USP or EP guidelines or dosage dependent
- Other API – specific parameters: tailored to specific needs
Tests and specifications can be changed on customer request
You must be logged in to post a comment.