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1. IMPURITY ISOLATION
2. IMPURITY SYNTHESIS
3. CERTIFIED IMPURITY STANDARDS
4. COST EFFECTIVE SCIENTIFIC SOLUTION
5. LYOPHILIZATION SERVICES
6. OTHER USER SPECIFIC SUPPORT
7. STRUCTURE INTERPRETATION
Isolation and purification of impurity from mg to g scale. We
have executed most critical isolation and purification project in
recent past, e.g isolation of unknown impurity from drug
product and APIs and and Structure elucidation.
We have synthesized impurities as on date. We offer custom
synthesis of impurity compounds on requests. For a quote on
this service please submit the following information:
A) Structure of the impurity.
B) Name of the parent compound.
C) Required quantity.
All products are supplied with certificates of analysis.
Standard certificates contain:
A) Identification by 1H-NMR and Mass spectroscopy.
B) Purity test by either HPLC or GC.
C) Other test like C13-NMR, TGA, IR & Elemental
Analysis will be provide on request.
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.
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,
tScreening of Genotoxic Impurities
tEvaluation & Estimation of Genotoxic
Impurities & Method Validation
tAnalytical Method Validation of
Pharmacopoeial Methods
tAnalytical Method Validation of
Related Substances (Impurity Profile)
tAnalytical Method Validation of
Residual solvents in ppm levels
tAnalytical Method Validation of Assay
(Chromatographic and potentiometric)
tAnalytical Cleaning Method Validation
of Rinsing and Swab method
tAnalytical Method Validation of Chiral
Method by HPLC
tInjectables, Syrups, Ointments
tFormulation Tablets, Capsules
tExcipients
tRaw Materials
tIntermediates and In-process
Samples
tIdentification by IR, UV, HPLC, GC, MR
tRelated Substances by HPLC, GC
tAssay by HPLC, GC, UV, Potentiometer
tResidual Solvents by Headspace
method and Liquid method
tLoss on Drying
tLimit Tests for Metals (As per
Pharmacopoeia method)
tResidue on Ignition Solubility test
tMelting Point and Range
OUR STRENGTH