Synthesis of Impurity | Isolation Purification of known and unknown Impurity | Medicinal Chemistry Services | Custom Chemical Synthesis Services

An ISO 9001:2008

Medicinal Chemistry Services at Veeprho Laboratories :
Our services include:
1. Synthesis of focussed libraries
2. Synthesis of Organic Scaffolds
3. Synthesis of NCEs
4. Custom chemical synthesis
5. Synthetic organic chemistry of all major chemotypes
6. Scale up to support in vivo efficacy and toxicity studies
7. Analytical method development
8. Commitment to achieve our customer’s goals

Isolation & Purification of known and unknown Impurities from mg to gm scale is done by our extremely talented team of scientists. We have executed most critical isolation and purification projects in the recent past, e.g Isolation & Purification of known and unknown Impurity from drug product, API's and Structure elucidation.

Structure Interpretation

Study of spatial heterogeneity of reactants, products, or conditions by using 2-D NMR techniques involving Homonuclear correlation experiments like NOESY, DQF-COSY, TOCSY, ROESY and Heteronuclear correlation experiments like HMQC, HSQC, HMBC.

Quantification studies by NMR.
MS/MS studies and mass accuracy up to 4th decimal - Q-TOF.
For volatile / neutral molecules with less than 500 amu GCMS,

Our lab is equipped with:

1. Virtis 25EL Lyophilizer.
2. Waters Prep HPLCs with PDA.
3. Waters HPLCs with PDA and UV.
4. LCMS.
5. UV Spectrophotometer-Shimadzu.
6. pH meter, other all small equipment.

We have synthesized more than 2500 impurities as on date. VEEPRHO offers custom synthesis of impurity compounds on requests. For a quote on this service please submit the following information:

1) Structure of the impurity.
2) Name of the parent compound.
3) Required quantity.

All VEEPRHO products are supplied with certificates of analysis. We are supplier and manufacturer of impurity standards. Impurity standard certificates contain:

1. Identification by 1H-NMR and Mass spectroscopy.
2. Purity test by either HPLC or GC.
3. Other test like C NMR, TGA, C NMR, CHN, IR will be provide on request.

Extensive Analytical Method Development and Validation Services.

Method validations are performed to meet current ICH (International Conference on Harmonisation) guidelines. We can develop and write the protocol for method validations. Often, method development and validation are linked in an overall project design. Once a method is shown to be workable, validation protocols are prepared and experiments are executed to FDA/ICH guidelines for method validation.

Standard operating procedures are prepared and methods transferred to client laboratories. Analytical problem solving activities include identification of unknown peaks, evaluation of methods with new products or processes, and investigation of faster and simpler analytical alternatives. The same tools are frequently used to troubleshoot processes.

Assay and related substances.
Chromatographic purity.
Stability indicating assays.
Forced degradation studies.
Cleaning procedures.
Characterization of reference standard and drug substances.
Process validation support.
Method transfer/training.
Comparative studies.
Reference standard qualification.
Working standards.
Vendor qualification.

VEEPRO offers world class service in chemical synthesis of a wide variety of organic compounds on the milligram to kilogram scale at competitive price.

- Multistep organic synthesis.
- Asymmetric synthesis using chiral auxiliary, catalysis, and resolution techniques.
- Metal-mediated reactions.
- Hydrogenation.
- Toxic chemistry.
- Peptide synthesis.

Our Most Frequent Custom Synthesis Requests:
Small molecules

- Intermediates, APIs.
- Reference compounds.

After Isolation Purification of known and unknown Impurity from APIs and Drug products and it is be analyzed by LC-MS, HPLC, H and C NMR, FT-IR and elemental analysis (CHNS) to confirm its structure.

We are supporting our clients during their development work, validation, ANDA/DMF filing and we also support them if any FDA query comes after filing. And Data Interpretation with proper justification that will be acceptable to FDA.

We are manufacturing impurity in gm level. Our prices are lowest prices in the world.

We are providing this typical service, all kinds of sample which are very sensitive to temperature.
We have Virtis 25EL, Capacity of freeze drying is 500 g/day.

We are supporting our client for analytical method development, formulation development, in-vitro-invivo studies, preformation studies, impurity profiling, leaching study, tech-tanfer issues and FDA query response.

Our team keeps on reviewing latest pharmacopial monograph and also keeps the impurity standards with certification ready to save the time of our users.

Keywords : Isolation Purification of known and unknown Impurity, Medicinal Chemistry Services, Custom Chemical Synthesis Services, Synthesis of Impurity, Certified Impurity Standards Manufacturer, Impurity Standards Supplier, Impurity Isolation