02 — Analytical Development

Analytical evidence your dossier can stand on.

Analytical work sits inside the development programme rather than downstream of it. Methods are built as the formulation takes shape, together with product development and quality assurance, so every batch decision rests on data that has already been validated. The same team takes standalone analytical work, including method transfer into a partner’s laboratory.

OutcomePartners receive validated, transferable methods and the analytical sections a regulator expects to read.

Specialised studies, from nitrosamines to IVRT/IVPT: 5; Specialised studies, from nitrosamines to IVRT/IVPT
Years of analytical R&D leadership: 20+; Years of analytical R&D leadership
Stability and impurity work to ICH guidelines: ICH; Stability and impurity work to ICH guidelines

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The method lifecycle

01DevelopMethods for finished products and intermediates, built around the product’s critical quality attributes.
02ValidateValidation to ICH expectations, so the method is fit for the decisions it will support.
03TransferTransfer to the receiving laboratory or manufacturing site, with the data to prove equivalence.
04VerifyVerification of compendial and transferred methods, plus cleaning-method development and validation.

Impurities, elemental impurities and E&L

Impurities decide whether a product is filed or delayed. Our analytical leadership works to identify and characterise them early, with experience in risk assessment for residual solvents, elemental impurities and nitrosamines.

Impurity profiling and characterisation
Evaluation of elemental impurities to ICH guidelines (Q3D)
Extractables and leachables testing
Pre-formulation studies

Specialised analytical studies

Studies that regulators increasingly expect for complex generics and differentiated products, run in-house alongside the development programme.

Nitrosamine studies
NG tube studies
Elemental impurities
IVRT and IVPT studies
Phosphate binding studies

Stability

Development stability studies to ICH guidance, in temperature- and humidity-controlled chambers and photostability chambers. Stability data sets the shelf life claim and exposes formulation weaknesses while they can still be fixed.

Dissolution and product performance

Performance testing shows how the product behaves in the patient, and supports comparisons with the reference product.

Dissolution with USP apparatus I, II and III, with autosampler
Intrinsic dissolution
Franz diffusion cells for topical products
Particle-size analysis from micron to nano scale

Regulatory analytical support

The team that generated the data writes the analytical sections of the dossier and answers the reviewer’s questions on them. Our analytical leadership has supported submissions for the US and Europe, including QbR, OOS and OOT investigations and query resolution.

InstrumentationV-24

Separation, mass spectrometry, elemental analysis and stability capacity on site.

LC-MS/MS
GC-MS
ICP-MS
Shimadzu HPLC with UV detection
Dionex ion chromatography
UV and UV-visible spectrophotometers
Dissolution apparatus, USP I, II and III (Electrolab)
Franz diffusion apparatus
Particle-size analyser (micron to nano)
Stability and photostability chambers
Karl Fischer titrator, viscometer, conductivity meter

Next capability03 Technology Transfer

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Where does your programme stand?

Tell us the molecule, the dosage form and the market you are filing in. A programme lead will read it and reply with what we would do next.

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Business enquiries: vasanthi@kmshc.com · +91 97898 75194V-23

KMS PharmaChennai