Allmpus offers its customers wide range of analytical chemistry services most promising results with rapid/short time lines. The services include quantitative and qualitative analysis, structural confirmation, chemical characterization and purifications (achiral and chiral) are performed as needed using advanced technologies.

The analytical team provides support to discovery and process chemistry groups as an integrated service or a stand-alone option for our customers. Our unique approach allows us to identify and evaluate the chemical in our analytical testing laboratories rapidly and effectively communicate the resulting data to help our customers understand the product’s chemistry.

Analytical Solutions - R&D

Fully equipped of Analytical Laboratory set up is available for R&D support, day to day routine analysis and finished products analysis

1. HNMR – 400MHZ
2. HPLC/UPLC with PDA, UV, ELSD and CAD detectors - 06 Number
3. LC_Ms - 01 Number
4. Preparative HPLC- 01 Number
5. Preparative DAG HPLC - 01 Number
6. IR infrared spectroscopy - 01 Number
7.  TGA thermogravimetric - 01 Number
8. lyophilizer freeze dryer - 01 Number
9. Melting point apparatus
10.   Ph Meter apparatus
11.   Sonicator
12. UV-Vis spectrophotometer

Analytical Solutions -Formulation Studies & Developments

1. Analytical Method Development, Analytical Method Validation and Technology Transfer.
2. Cleaning Method Development & Cleaning Method Validation
3. Dissolution Studies
4. Extractable and Leachable
5. Ink & Gum Migration Studies
6. Glass Delamination Studies
7. Naso Gastric (NG Tube) In Vitro Studies
8. Residual Solvent Studies
9. Pharmacopeial Monograph Testing
10. Purposeful Degradation Studies
11. QC Testing for Batch Release
12. Speciation Studies and Analysis
13. Elemental Analysis
14. Organic Elemental Analysis
15. Nitrosamine and NDSR (N-Nitrosamine) Impurity Analysis
16. Genotoxic Impurity Analysis
17. Stability and Release Testing
18. Phosphate and Kinetic Binding Studies

Infrastructure (Analytical Instruments) Details & Capabilities

• High Performance Liquid Chromatography (HPLC)
• Dissolution Testers
• Karl Fisher Titrator
• Ultraviolet–visible spectroscopy (UV)
• Stability Chambers
• Liquid Chromatography with tandem mass spectrometry (LC MS/MS)
• Gas chromatography–mass spectrometry (GC-MS)
• Inductively coupled plasma mass spectrometry (ICP-MS)
• Ion Chromatograph (IC)
• CHNS (O) Elemental Analyzer
• Gas chromatography (GC)
• Atomic absorption spectroscopy (AAS) with Hydride Generator

Analytical Method Development/Validation for CMC

• HPLC-UV/PDA/ELSD/Chiral methods for in-process, intermediates and NCE API
• Impurities/Assay by HPLC/UPLC – as per ICH Q3
• Elemental Impurities/ (ICP-OES/MS) – as per ICH Q3D
• Forced degradation study
• ICH compliant stability studies – as per ICH Q1A
• Residual solvents analysis by GC as per ICH guidelines
• GMP

Purification

• Preparative purification and isolation (milligrams to multi Kg)
• Chiral/achiral purifications (milligrams to multi Kg)
• Isolation of impurities, metabolites, natural products and degradation products.

Structure Elucidation

• Structure elucidation of new chemical entities (NCE’s), impurities, degradation products, metabolites and natural products.
• Structure elucidation by LC-HRMS, NMR, FT-IR & UV-Visible.
• X-Nuclei NMR (1H, 2H, 7Li, 11B, 13C, 15N, 19F, 23Na, 27Al, 29Si, 31P, 119Sn, 195K)
• NMR special experiments (2D-NOESY, COSY, HMBC, EDHSQC, Selective Gradient 1D-NOESY / ROESY, TOCSY, 2D-ROESY, DOSY, H2BC, etc.,)

Solid State Characterization

• Solid state analysis (DSC, TGA and XRPD)
• Crystallization studies
• Polymorph screening
• Polymorph characterization
 

Physicochemical Study

• Melting point
• Solubility
• pKa
• Log P determination
• Optical rotation
• Elemental analysis
• Solid state analysis (DSC, TGA and XRPD)
• Polarimetry
• KF Titration
• IR Spectroscopy
• Impurity Profiling
• Isolation of impurity
• Structure elucidation
• Impurity synthesis