Analytical standards for usp: How certified reference material suppliers work?
Whether natural products or synthesized drug processes, both have a final goal to be as pure as possible. This is why API formulation makers are able to grow and evolve with the help of certified reference material suppliers to address various quality related factors. Analysis of drug substances need to meet the reference standards qualified by the authorities.
SimSon Pharma Limited continues to follow working standard qualification as per usp with accuracy. We believe in collaborating with other stakeholders to meet the reference standards, pharmaceutical industry, and other diverse clients requiring our services.
We have a focused goal of meeting protocols regarding measurement, data analysis, innovations and testing samples. Our company succeeds because of usage of high technology, experienced staff and speed at which we offer the analytical standards.
Categories of reference standards
· Assays: To determine the potency in salts and APIs.
· Degradation products: Quantitate them and identify them easily through testing.
· Impurities processing: Earmark process related compounds.
Resolution: Determine assay performance and impurity method qualifications.
Once the working standard and reference standard is established the drug undergoes routine analysis for various quality related controls. It can pertain to any manufacturing batch in the lab. All certified reference material suppliers work towards traceability to a global standard authority. Once the formulation is made it has to be stored under prescribed conditions. Specialists who have industry knowledge deal with the proficiencies test of reference materials with the samples. Certified suppliers source standards for businesses involved in Life Sciences, Pharma, Health, Environment, research and Food & Beverages.
Projects to qualify materials
Reference standards can be compendial or in-house. Primary sources are USP or EP which are set by various global agencies. We are open to helping our customers by:
· Determining the product assay
· Checking for impurities in the samples
· Releasing raw materials
· Monitoring the processes of manufacturing
· Retention time reference marker
· Studies for stability and analysis
API manufacturing requires scale up for each manufacturing batch. To meet various challenges, it is essential to follow the working standard and reference standard. It is a must to check the following six stages:
· Quality check
· Validity of working standard
· Shelf life study
· Intermediary checks
Scope of certified reference material suppliers
When you deal with the right company the scope of work is well defined. It will encompass:
· Customized work for inorganic, single and multiple components.
· ICP and Internal standards
· Modifiers, agents and pH buffer CRMS
· Customized analytical CRMS
· Volumetric & Conductivity CRMS
What makes us different is the experience and capability to handle manufacturing processes. Our team ensures:
· Stock availability and the purchase of raw materials
· Sources for complete traceability
· Calculate the correct weights, gravimetric process for best analytical performance
· Evaluation of the final data to measure certified values and any uncertainty
· Make labels and certifications
· Ensuring final control of products that have to be exported with accompanying documents
SimSon Pharma Limited has built strong relationships over a period of many years with diverse clients across countries. We are a one stop source for working standard qualification as per usp. Talk to us about your specific sampling and how we can collaborate to provide the best analysis.