Impurities in pharmaceutical products are the unwanted chemicals that remain with the active pharmaceutical ingredients (APIs), or develop during formulation, or upon aging of both API and to medicines. The presence of these impurities even in trace amounts may influence the efficacy and safety of the pharmaceutical products. Identification and quantification of impurities (Impurity Profile) is now becoming important critical product quality parameter and getting critical review from regulatory authorities. Because of this, limit and threshold values for impurities are specified by pharmacopoeias and ICH guidelines. Analysis of impurities according to this set of specifications is mandatory for the pharmaceutical product release for the human consumption. Impurity Profile study is also very important for market approval for finished dosage forms from regulatory authorities.
The identification and quantification of impurity in the pharmaceutical product is carried by using Certified Impurity Standards of known purity. It is recommended to use Impurity Standard having purity at least 90.0 per cent when used for peak identification in the chromatogram or use in the system suitability test for resolution and minimum 95.0 per cent when used to estimate the content of a specified impurity.
Oceanic Pharmachem offers a wide range of high purity Impurity Standards for the pharmaceutical industries on the milligram to kilogram scale at competitive price. Oceanic Pharmachem has a technical capability to Synthesize, isolate and purify the Impurity Standards to their purest form. Oceanic Pharmachem can offer the Impurity Standards from mg to gm scale.
Oceanic Pharmachem offers custom synthesis mg to gm level of impurity compounds on requests. In case of non-standard Impurity Standard additional study for Structure Elucidation, Characterization, Analytical Method Validation are also undertaken using state – of – the – art equipment like; LC-MS, HPLC, H and C NMR, FT-IR and elemental analysis (CHNS), etc.
All Oceanic Pharmachem products are supplied with certificates of analysis (CoA). Standard certificates contain:
1. Identification by 1H-NMR and Mass spectroscopy.
2. Purity test by either HPLC or GC.
3. Other test like C NMR, TGA, C NMR, CHN, IR will be provide on request.
Shipping and Transportation:
Oceanic Pharmachem understands the needs of industry. Our standards are shipped with a Certificate of Analysis, MSDS and all the required documentation to ensure a smooth clearance. We transport the standards in a manner that protects the integrity and efficacy of the product.
DISCLAIMER: Products under Patent for Research and Development and/or for experimental use and not for commercialization.Sale of the products is limited to those exempted under Section 107A(a) of the Patents Act. 1970 in India.Under 35 U.S. code § 271(e)(1) in USA and under EC Directives 2001/82/EC (as amended by Directive 2004/28/EC) and 2001/83/EC (as Emended by Directives 2002/98/EC, 2003/63/EC and 2004/27/EC) in European Union and such similar statutes as may be in force/applicable in various other territories/countries.