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:
·
Sourcing
·
Storage
·
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
·
Reagents
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.