PHARMACEUTICAL REFERENCE STANDARDS FAQs

SimSon Pharma supplies pharmaceutical reference materials for analytical research and method development, including drug impurity standards, working standards, metabolites, nitrosamine impurity standards, stable isotope labelled compounds, calibration standards and research chemicals. You can search the product catalogue by product name, catalogue number, CAS number or molecular formula.

SimSon Pharma can evaluate requests for impurity standards, labelled impurities and nitrosamine impurities associated with controlled APIs. Supply is subject to product availability, applicable licences, end-use documentation and the import or controlled-substance requirements of the destination country. Please contact our technical team with the API name, target impurity and required quantity for a compliance review.

Accreditation applies only to the legal entity, facility, activity and scope stated on each certificate. Review the current certificate and scope on our quality and accreditations page before using it for supplier qualification.

Products pass through three operational checkpoints: review at the manufacturing or qualification stage, control during inventory management, and verification before dispatch. The exact tests, acceptance criteria and assigned values are product- and batch-specific; the supplied Certificate of Analysis (CoA) is the authoritative document for the material received.

SimSon Pharma’s published technical and manufacturing network includes facilities in Ahmedabad, Hyderabad and Vasai, India, supported by its Mumbai corporate office. Activities and accreditation scopes differ by location, so customers should confirm the responsible facility in the applicable quotation, CoA or current accreditation document.

The data package depends on the material and its intended use. An impurity standard package may include identity and purity evidence from techniques such as ¹H NMR, ¹³C NMR, mass spectrometry, IR, HPLC and TGA. An analytical standard package may also include loss on drying, water content or sulphated ash where relevant. Always use the tests, results and assigned value reported on the product-specific CoA rather than assuming that every technique applies to every batch.

Yes. Request the current product-specific Safety Data Sheet (SDS, formerly called MSDS) using the product name and catalogue or batch number. Indian customers can email info@simsonpharma.com; international customers can email exports@simsonpharma.com. The SDS supports hazard communication and safe handling; it does not replace the CoA.

Retention time (RT) is the elapsed time between sample injection and the maximum response of a chromatographic peak at the detector. RT can support identification when the sample and reference standard are analysed under the same validated chromatographic conditions. It is not a universal constant: column chemistry, mobile phase, flow rate, temperature, instrument configuration and system condition can all affect it.

Relative retention time (RRT) is commonly calculated as the retention time of the analyte or impurity divided by the retention time of a specified reference peak in the same method. RRT helps compare peak positions and can reduce the effect of small run-to-run RT shifts. The reference peak and calculation convention must be defined in the analytical method; RRT alone is not conclusive proof of identity.

Chiral HPLC is appropriate when stereochemical purity is a relevant quality attribute—for example, when an enantiomer must be measured in the presence of its mirror-image form. Conventional achiral HPLC often cannot resolve enantiomers because they have similar behaviour in an achiral environment. A validated chiral method uses a chiral stationary phase or selector and must demonstrate suitable specificity, resolution and sensitivity for the intended application.

The retest period is assigned for the individual material and batch using available stability knowledge, chemical characteristics and the defined packaging and storage conditions. Refer to the vial label and CoA for the applicable retest date. A retest date is not the same as an automatic expiry date; after that date, the material should not be used as a standard unless its suitability has been reassessed and supported by current documentation.

Do not assume that an appearance change is harmless. Hygroscopicity, solvent loss, polymorphic change, oxidation, light exposure or shipping conditions can alter a material’s appearance. Quarantine the vial, compare the observed appearance with the label and CoA, review the storage history, and contact our technical team with the catalogue number, batch number and photographs before use.

An unopened-container retest period does not by itself establish stability after opening. Unless product-specific in-use stability data are stated in the supplied documentation, users should perform a risk assessment based on the material’s hygroscopicity, light and oxygen sensitivity, storage history, handling frequency and analytical purpose. Open and weigh the material under suitable controlled conditions defined by your procedure and the product documentation.

Repeated use may be acceptable only when it is supported by the product documentation and your laboratory’s risk assessment. Minimise the time the vial is open, use clean tools, prevent contamination and return it promptly to the stated storage condition. Use a dry or inert atmosphere only when required by the CoA, SDS or an approved handling procedure. For sensitive materials, single-use aliquots may provide better control.

There is no universal post-opening expiry period or safe number of opening cycles for reference standards. The limit depends on the material, container closure, headspace, quantity remaining, handling environment and evidence of stability. Follow the product-specific documentation and your laboratory SOP. Record each opening where required, and contact our technical team if an in-use period is needed for a regulated method.

SimSon Pharma supplies customers in international markets. Availability and shipping depend on the product classification, destination-country import requirements, carrier acceptance and any licence or end-use documentation required. Send the delivery country, product name, catalogue number and quantity to exports@simsonpharma.com for a feasibility and lead-time review. See the shipping policy for additional information.

Return, replacement and refund requests are reviewed against the product condition, documentation, reason for return and applicable terms. Because reference materials and research chemicals may have specific storage, safety and chain-of-custody requirements, do not send material back without authorization. Review our return policy and contact support with the order, catalogue and batch numbers.

After dispatch, the available courier and tracking details are shared with the ordering contact. Use the tracking number on the courier’s website for shipment updates. If tracking has not updated or the consignment appears delayed, contact customer support with your order number and delivery destination.