Comprehensive Pharmaceutical Compendial Testing & USP Compendial Testing From NJ Labs
Compendial testing refers to specifications as defined in pharmacopeia or compendia, which are established quality standards and methods for evaluating the identity, purity,
strength, and other quality attributes of raw materials, API (Active Pharmaceutical Ingredients) and finished products. Compendial testing plays a crucial role in the pharmaceutical industry by providing a standardized framework for quality control testing, ensuring consistency and comparability of results across different manufacturers and regulatory authorities. But Compendial testing is also starting to play a role in the nutraceutical industry as more and more supplements attract scrutiny by the FDA. Fortunately, the USP also has standards for supplements companies to follow that apply the same quality best practices used in the pharmaceutical industry. These standards ensure that drugs and other finished products are safe, effective and of high quality.
NJ Labs offers comprehensive compendial testing that meet the USP (US Pharmacopoeia), but we also work with other compendia including the EP (European Pharmacopoeia), BP (British Pharmacopoeia) and JP (Japanese Pharmacopoeia). Examples of the kinds of compendial tests we perform include: identification tests, assay methods, tests for impurities, microbial limits testing, bio-burden testing and sterility testing, among others. All compendial testing at NJ Labs is performed per CGMP standards of 21 CFR 210, 21 CFR 211, 21 CFR 111 and 21 CFR 117
USP Compendial Testing at NJ Labs
Below are the most common general chapter tests we perform but we also perform many analyses by partial or full momographs in the official USP:
| USP Chapter | Test |
| <61><62> | Suitability Testing • Suitability of the Counting Methods in the Presence of Product. • Suitability of the Test Methods in the Presence of Product. |
| <2021><2022> | Preparatory Testing |
| <51> | Antimicrobial Effectiveness Testing |
| <60> | Burkholderia cepacia complex (Bcc) |
| <61> | Microbial Enumeration Testing • Total Aerobic Microbial Count • Total Yeasts and Molds Count |
| <62> | Bile Tolerant Gram Negative Bacteria |
| <62> | Escherichia coli (E.coli) |
| <62> | Salmonella |
| <62> | Pseudomonas aeruginosa Staphylococcus aureus |
| <62> | Clostridia |
| <62> | Candida albicans |
| <85> | Endotoxins |
| <197> | Spectrophotometric Identification Test |
| <201> | Thin-Layer Chromatography Identification Test |
| <211> | Arsenic |
| <221> | Chloride and Sulfate |
| <228> | Ethylene Oxide and Dioxane |
| <232> | Elemental Impurities – Limits |
| <233> | Elemental Impurities – Procedures |
| <241> | Iron |
| <251> | Lead |
| <281> | Residue On Ignition |
| <291> | Selenium |
| <311> | Alginates Assay |
| <401> | Fats and Fixed Oils Acid Value, Sap Value, Hydroxyl value, Iodine value (method I & II), Unsap value, Fatty Acid Composition. Omega-3 Fatty Acids Determination and Profile, Peroxide value |
| <467> | Organic Volatile Impurities |
| <469> | Ethylene Glycol, Diethylene Glycol, and Triethylene Glycol in Ethoxylated Substances |
| USP Chapter | Test |
| <471> | Oxygen Flask Combustion |
| <525> | Sulfur Dioxide |
| <541> | Titrimetry |
| <616> | Bulk Density And Tapped Density Of Powder |
| <621> | Chromatography (GC. HPLC and HPTLC) |
| <643> | Total Organic Carbon |
| <645> | Water Conductivity |
| <651> | Congealing Temperature |
| <701> | Disintegration |
| <711> | Dissolution |
| <721> | Distilling Range |
| <731> | Loss On Drying |
| <733> | Loss On Ignition |
| <741> | Melting Range or Temperature |
| <781> | Optical Rotation |
| <781> | Particle Size Distribution Estimation by Analytical Sieving |
| <791> | pH |
| <831> | Refractive Index |
| <841> | Specific Gravity |
| <851> | Spectrophotometry and Light-Scattering |
| <905> | Uniformity of Dosage Units |
| <911> | Viscosity-Capillary Viscometer |
| <912> | Viscosity-Rotational Rheometer Methods |
| <921> | Water Determination by KF (Karl Fischer) |
| <2021> | Bile Tolerant Gram Negative Bacteria |
| <2022> | Escherichia coli (E.coli) |
| <2022> | Salmonella |
| <2022> | Staphylococcus aureus |
| <2022> | Clostridia |
| <2040> | Disintegration and Dissolution of Dietary Supplements |
| <2091> | Weight Variation of Dietary Supplements |
Other Compendial Testing Specialties Which NJ Labs Performs
Compendial raw materials testing is an essential process in the pharmaceutical, nutraceuticals/dietary supplements, foods, and other regulated industries to ensure the quality, safety, and efficacy of final products. NJ Labs specializes in performing compendial raw materials testing to help identify and prevent the use of substandard materials, thereby ensuring the safety and efficacy of the final products that consumers rely on.
Compendial Excipients Testing
Excipients are substances used in drug formulations to facilitate the manufacturing process, enhance stability, or improve drug delivery. Compendial excipients testing helps pharmaceutical companies select and use high-quality excipients, leading to safe, effective, and consistent drug products for patients.
API Compendial Testing
Active Pharmaceutical Ingredients (API) compendial testing ensures the quality, safety, and efficacy of the active ingredients used in drug formulations. API compendial testing plays a crucial role in pharmaceutical quality control, as it verifies the active ingredient is of consistent quality and meets established standards that ultimately ensure the safety and efficacy of the final drug product. In supplements, amino acids can also be an API calling for compendial testing.
Finished Products Compendial Testing
Finished products compendial testing ensures that the final drug product meets established quality, safety, and efficacy standards. It ensures that the final drug product meets the required standards, offering safe and effective treatments to patients. Regulatory authorities often require evidence of compendial testing to approve and monitor the marketing of pharmaceutical products.
Gas chromatography (GC) is also a versatile analytical technique because it can be used to analyze a wide range of compounds, including gases, liquids, and solids. Here are some examples of compounds from that can be analyzed using gas chromatography:
Compendial Testing For Nutraceutical/Dietary Supplements Product Manufacturers
Compendial testing is important for this industry because nutraceutical/dietary supplements products combine the characteristics of both nutrition and pharmaceuticals. They typically include dietary supplements, herbal products, functional foods, and other similar products. The USP has a whole set of monographs for dietary supplements In addition, the FDA has guidance documents for the supplement industry. https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/dietary-supplements-guidance-documents-regulatory-information.
Here are the key reasons why nutraceutical manufacturers should consider a compendial testing program:
- Quality Assurance: Compendial testing helps ensure the quality and safety of nutraceutical products. It involves testing the raw materials, active ingredients, and finished products against established standards to verify their identity, purity, strength, and composition. This can help identify any potential contaminants or adulterants, ensuring that consumers are receiving products that meet their intended specifications.
- Consumer Trust and Confidence: By voluntarily adhering to compendial testing standards, nutraceutical companies can build trust and confidence among consumers. When customers know that a product has undergone rigorous testing and complies with recognized quality standards, they are more likely to trust the product and the brand.
- International Market Access: Compendial testing follows well-established standards and methods, often set by respected organizations like the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), or the British Pharmacopoeia (BP). Adhering to these standards can facilitate international market access since many countries recognize and value products that meet these global quality benchmarks.
- Regulatory Compliance Preparedness: While compendial testing might not be mandatory at present, regulations and requirements can change over time. By already implementing these practices, nutraceutical companies can be better prepared for any potential future regulatory changes. It can save time and resources in case the authorities decide to enforce compendial testing as a requirement in the future.
- Risk Management: Compendial testing can help mitigate risks associated with product quality and safety. By identifying potential issues early on, nutraceutical companies can take corrective actions and prevent potential recalls or legal challenges that could arise from using substandard or contaminated ingredients.
- Industry Credibility and Standardization: Adopting compendial testing practices can contribute to the overall credibility of the nutraceutical industry. It demonstrates a commitment to upholding high-quality standards and aligning with the practices used in pharmaceutical and other highly regulated industries.
In summary, compendial testing for the nutraceutical industry offers numerous benefits in terms of quality assurance, consumer trust, international market access, regulatory compliance preparedness, risk management, and industry credibility. NJ Labs currently tests both pharmaceutical and nutraceutical products and so we are at the crossroads of both these industries. And in addition to being FDA, DEA Registered & Inspected, we are also an ISO: 17025:2017 Accredited, CGMP certified laboratory. We can help you with compendial testing that can contribute to your long-term success and sustainability while prioritizing the health and safety of your consumers.
References:
- United States Pharmacopeia (USP):
- Official Website: https://www.usp.org/
- USP-NF Online: Access to the United States Pharmacopeia-National Formulary (USP-NF) standards requires a subscription: https://online.uspnf.com/
- European Pharmacopoeia (Ph. Eur.):
- Official Website: https://www.edqm.eu/
- European Pharmacopoeia Online: Access to the European Pharmacopoeia (Ph. Eur.) requires a subscription: https://www.edqm.eu/en/european-pharmacopoeia-ph-eur-10th-edition
- British Pharmacopoeia (BP):
- Official Website: https://www.pharmacopoeia.com/
- British Pharmacopoeia Online: Access to the British Pharmacopoeia (BP) requires a subscription: https://www.pharmacopoeia.com/bp-2022
- Japanese Pharmacopoeia (JP):
- Official Website: https://jpdb.nihs.go.jp/jp17e/
- Japanese Pharmacopoeia Online: Access to the Japanese Pharmacopoeia (JP) requires a subscription: http://jpdb.nihs.go.jp/jp17e/
- International Pharmacopoeia (Pharmacopoeia Internationalis):
- Official Website: https://www.who.int/publications/i/item/pharmacopoeia-internationalis
- The International Pharmacopoeia is published by the World Health Organization (WHO). Some editions and monographs can be accessed freely on the WHO website.