Custom Synthesis of Pharmaceutical API Impurities / R&D compounds

SynThink Research Chemicals is leading custom synthesis provider of Pharmaceutical API Impurities & R&D compounds in India.

Sometimes, it becomes very difficult task to find some impurity standards and R&D compounds within time due to various reasons. So, It is always a matter of worry within different departments of a pharmaceutical companies. At SynThink Research Chemicals we are committed to provide custom synthesis of R&D compounds and API Impurities (Pharmacopial and non-pharmacopial Reference Standards) as per your requirement in a timely manner.

In cases when required pharmaceutical API impurity standards or R&D compounds are not available anywhere, they needs to be custom synthesized. In such cases clients just need to send the available details of the required products like name, IUPAC name, structure, CAS number etc. and rest will be taken care by our R&D team.

Custom Synthesis / manufacturing of pharmaceutical Impurities and R&D Compounds at Synthink

At Synthink, we produce / manufacture / synthesize pharmaceutical API impurity standards or R&D compounds using reliable scientific processes / techniques like organic synthesis techniques, degradation, enrichment and various isolation techniques e.g. chromatography techniques etc.

We offer synthesis of pharmacopeial and non-pharmacopeial Impurity standardsincluding – Degradation Impurities, Process Impurities, Potential Impurities, KSM impurities, API impurities etc.

While doing impurity profiling or any analytical study of a API, factors like water content, volatile content, potency, retention time (RT), relative retention time (RRT), response factor (RF), relative response factor (RRF) are very important. So, during synthesis / manufacturing process we keep these important factors in mind and produce and supply the highest possible quality material accordingly.

Generally custom synthesis products would be shipped in the in 3-6 weeks (as per difficulty level of the product and time mentioned in quote / proposal).

Degradation, Isolation and purification service is also provided as per clients’ request.

All Pharmaceutical impurities / related compounds are provided with certificate of analysis (CoA) along with the complete characterization data like 1H-NMR, IR, MASS, HPLC Purity etc. On request, we also provide additional data like 13C-NMR, 13C-DEPT, HMBC-NMR, HMQC-NMR, COSY-NMR, NOESY-NMR, NOE-NMR, CHN, TGA, Water Content, Volatile Content, Potency, Assay etc (with extra charge/fees).

Click here to check sample CoA along with characterization data.

Quality of the material

At SynThink, we are aware that Characterization and data integrity of the impurities is highly important factors to our clients / FDA. We have placed strict internal standard operating procedures. So, our quality control (QA) and quality assurance department check / analyze all data of every impurity batch very carefully as per strict internal standard operating procedures. By doing critical analysis at every stage Synthink is able to provide accurate characterization and data of every impurity batch. We can also share the electronic copy of CoA and data by email before delivering the material to the client to get confirmation from end user so client won’t get any surprise.

Structural Elucidation Reports (SER)

In many cases client has some special requirements like, Structural Elucidation Reports (SER), Characterization Report or Peak Assignment Reports. On request we can provide such additional services with appropriate charges. Based on requirement we do additional required experiments like 13C-NMR, 13C-DEPT, HMBC-NMR, HMQC-NMR, COSY-NMR, NOESY-NMR, NOE-NMR, CHN, TGA etc.

Clients can also provide their own material to get these services from SynThink.

For sample Structural Elucidation Reports (SER), Characterization Report or Peak Assignment Reports, please send us a request.

Please send online enquiry or just email us with product details and requirements. We will get back to you with availability / lead time and quote.

Send us a custom synthesis enquiry or email us – enquiry@synthinkchemicals.com

After sales support:

After successful delivery of the project if you still have any query, doubts or problems you can write to us at – support@synthinkchemicals.com. We will be happy to sort out your queries.

Process for ordering pharmaceutical impurity standard using SynThink’s custom synthesis services:

Here is step by step process for ordering pharmaceutical impurity standard using SynThink’s custom synthesis services

Client sends us a custom synthesis requirement details by an email – enquiry@synthinkchemicals.com or website enquiry form
Our R&D team studies the requirement.
If feasible, we send proposal with availability / lead time, quote and payment terms.
Client’s acceptance of proposal / quote.
After acceptance of proposal actual custom synthesis of impurities starts at our R&D Lab.
Client will be informed periodically about the progress of the project.
It there is any change / delay, will be inform to client.
After successfully getting the required impurity in had we send data to client.
Once we get confirmation from client we raise the invoice and ship the material.
Client need to pay according to terms and conditions given in proposal / quote.

Note: OUR CLIENTS NEEDS TO PAY ONLY AFTER SUCCESSFUL DELIVERY OF THE PROJECT / MATERIAL.

In some cases, we may ask advance payment.

One can also request other business modes like – FTE (Full Time Equivalent)

Keywords: Impurity, Related Compound, Reference Standard, EP Impurity, USP Impurity, Pharmaceutical Standard, impurities for ANDA filing, Analytical standard of , Degradation Impurity, Process Impurity, Potential Impurity, Unknown Impurity, API Impurities, impurity profiling, potency of impurity, retention time (RT) of impurity, relative retention time (RRT), response factor (RF), relative response factor (RRF) of impurity, price of impurity, manufacturer of impurity, supplier of impurity, cost of impurity, manufacturer of impurity in India, supplier of impurity in India.

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Custom Synthesis of Pharmaceutical API Impurities / R&D compounds

Custom Synthesis / manufacturing of pharmaceutical Impurities and R&D Compounds at Synthink

Quality of the material

Structural Elucidation Reports (SER)

After sales support:

Process for ordering pharmaceutical impurity standard using SynThink’s custom synthesis services:

SynThink Research Chemicals

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