What are pharmaceutical reference standards?

 

The drug reference standard is a standardized substance that's utilized in the pharmaceutical industry as a base of measurement for similar substances where the precise active substances of a new drug are unknown. A reference standard provides a calibrated level of biological effects to compare new preparations of the drug. Analytical drug reference solutions and patient education materials put the best available information into the hands of clinicians and patients. They simply analyze the information regarding dosage, efficacy, interactivity, and allergies, even suggesting alternate therapies as appropriate.

Drug reference standards are highly characterized physical specimens used in analytical testing by pharmaceutical and related industries to help ensure the identity strength, quality, potency, and purity of medicines, drugs, biologics, and excipients dietary supplements and food ingredients. All chromatographic reference standards are supplied with a certificate of analysis (COA) certifying the identification and purity of the compound. Drug reference standards are highly characterized specimens of drug substances excipient reportable impurities, degradation products compendial reagents, and performance calibrators. They are explicitly required in many pharmacopeial essays and tests and are provided solely for such use. assessment of the suitability for use of another application rests with the purchaser.

The pharmaceutical products market is a very fluid industry, new drugs are constantly being developed. And as older drugs come off patent, they're marketed with generics, expected and unexpected impurities can appear in drugs. At Symtera Analytics, our goal is to make sure that new reference standards are developed and available when our customers need them to get their own products to market.

Whether you're taking aspirin or prescription medication, you need to be confident that the drug will have the same high quality every time you buy it. Our commitment to providing you with the highest quality reference standards doesn't end with the product in your lab. We continued suitability for use team tests every one of the more than 20000 standards in our catalog on an ongoing basis to make sure that they are still suitable for their intended uses again and again. We test every standard according to its own requirements, identity, purity, appearance, moisture content with the monograph methods themselves. When that's done, we ensure the labeling still accurately describes the product inside.

To empower a healthy tomorrow is to develop new and high-quality reference standards for drug manufacturers throughout the world. So, that patients everywhere have access to the safe and quality medicines that they need.