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Pharmaceutical Impurities & Labeled Standards


Pharmaceutical standards are primarily classified into Impurity Standards and Stable Isotope Labeled Standards. These standards are essential to target unwanted impurities in pharmaceutical products. It is generally recommended to use impurity standards with >95% purity for quantifying the content of a specified impurity.

Daicel Pharma Standards offers a wide range of high-quality pharmaceutical standards of >95% and in quantities of milligram to multi gram scale. Our experienced chemists employ strict manufacturing protocols to produce effective, high-purity and high-quality products.

Impurity Standards:

The presence of impurities in pharmaceutical products, even in trace amounts, may influence the efficacy and safety of pharmaceutical products. Identification and quantification of impurities (Impurity Profile Study) is a critical quality parameter and carefully reviewed by regulatory authorities. Further, limits and threshold values for impurities are specified by pharmacopoeias and ICH guidelines. Analysis of impurities, according to this set of specifications, is mandatory for a product to be released for human consumption. Impurity Profile Studies are crucial for market approval, by regulatory authorities, of Finished Dose Forms.

Quantification of impurities in a pharmaceutical product is determined using Certified Impurity Standards of known purity/potency. Our impurity standards offer high purity for quantifying the content of a specified impurity.

Daicel Pharma Standards has a dedicated team of highly experienced scientists able to produce high-quality pharmaceutical standards. Our scientists are equipped with state-of-the-art infrastructure and integrated facilities consisting of Synthesis R & D, a purification facility, and an FDA-compliant analytical facility. Synthesis R & D is equipped with microwave synthesizers, Flash chromatography systems, rotary evaporators, and more. Our purification facility is equipped with Prep HPLC, Mass-directed Prep LC, Prep SFC, and Lyophilizer systems as well as rotary evaporators and a full range of chiral and achiral preparative columns. Our analytical facility is fully equipped with, but not limited to, LC-MS/MS, GC-MS/MS, ICP-MS, UPLCs, HPLCs, HS-GC, IC, KF, and TGA.

Stable Isotope Labeled Standards:

Stable isotope labeled standards are commonly used as internal standards in bio-analytical studies.

Daicel Pharma Standards has readily available shelf-stable, 2H and 13C labeled and non-labeled APIs, metabolites and glucuronides. As a rule, labeled standards are thoroughly checked and ensured to have no interference from the corresponding unlabeled compounds.

All Daicel Pharma Standards are supplied with certificates of analysis (CoA) from our US-FDA compliant analytical lab. Our standard CoA contains:

  1. Identification by 1H-NMR and mass spectrometry
  2. Purity test by either HPLC or GC
  3. Potency assignment post TGA study or Q NMR
  4. Other tests if requested by customer