Active Pharmaceutical Ingredients
Active Pharmaceutical Ingredients (APIs) are chemical entities in pure form used to manufacture drug products or to compound extemporaneous prescription drug products. Because of their intended use, it is highly important that these APIs meet strict quality and purity standards.
The quality of an API is determined by two essential factors- it must be the right chemical and it must have the right potency. Many API re-packagers rely on the manufacturer’s Certificate of Analysis (CofA) to ensure the quality of their API. At Humco, verifying the manufacturer’s CofA is only one of the many quality controls we use to ensure the packaged API is the right chemical and to ensure that it has the purity and potency expected.
Before Humco considers purchasing an API, we pre-qualify our suppliers to ensure that they manufacture the API under current Good Manufacturing Practices, as expected in ICH Q7A requirements.
Once the API is received, a statistical sample is taken and tested in our on-site laboratories. Through comprehensive and thorough testing, we ensure the identity of the API and that the potency meet the USP requirements and are comparable to the manufacturer’s CofA.
We use qualified and calibrated state-of-the-art analytical equipment under the Laboratory Controls delineated in 21 CFR 211. A few examples of these include:
- Fourier Transform Infrared Spectrophotometer (FTIR)
With this instrument, we can determine the identity of the API to ensure we package the correct chemical. This instrument gives us a spectral fingerprint of the chemical in question. We then compare this spectra with a known pure USP reference standard and ensure these two match.
- Ultra Violet/Visible Light Spectrophotometer (UV/Vis)
Similar to the FTIR, we can determine the identity of a specific API and it’s purity by comparing the absorption of a molecule at a specific wavelength versus a pure USP standard of known concentration.
- Identification by Chemical Reactions
By reacting the API in question with a chemical reagent, we can determine whether an API is its base or its related salt.
- Identification by Flame
Similar to the chemical reaction, we can determine if an API is its base or its salt. Some elements like sodium impart a specific color flame when burned.
- High Pressure Liquid Chromatography (HPLC)
Using this instrument we can further ensure the identity of an API and precisely and accurately determine its purity and potency.
- Gas Chromatograph (GC)
Similar to the HPLC, but using gas as a carrier, this sophisticated analytical instrument can help us ensure the identification, purity, and potency of an API.
- Thin Layer Chromatography
We can determine the identification and qualitative purity of an API using this analytical procedure.
By reacting the API with a known chemical of precise concentration, we can stoichiometrically determine the exact potency of the API.
Humco is committed to adhering to the highest quality standards to ensure that our products are consistently valued as the best option for patients and pharmacists.