Pharma & Nutraceuticals, NABL-accredited lab
Drugs & Pharmaceuticals
7 to 10 working days
Standard turnaround from sample receipt
NABL TC-5843
Accredited to ISO/IEC 17025:2017
HPLC with DAD, RID and FLD
Primary technique on this service
14,000 sq. ft.
Integrated laboratory in Jaipur
This service tests raw materials, intermediates and finished dosage forms against the pharmacopoeial monograph that governs them, covering assay, related substances, dissolution, residual solvents, elemental and nitrosamine impurities, and microbiology. Work is carried out under a CDSCO drug testing licence with GLP approval.
Batch release testing of an API or a finished formulation
Validating an in-house method to ICH Q2 before filing
Running accelerated or long-term stability under ICH zone IVb
A regulatory query, market complaint or supplier qualification
What we test on this service
Panels are built from the list below. Tell us the market and the specification and we select the parameters it calls for rather than selling you the whole sheet.
Assay, related substances and dissolution
Residual solvents by headspace GC
Elemental impurities under ICH Q3D
Nitrosamine impurity screening
Microbial limits, sterility and bacterial endotoxin
Stability studies under ICH zone IVb conditions
Method
How the analysis runs
Instrumentation and controls
Every batch runs with the controls its method requires, on calibrated equipment, and a second analyst reviews the data before the report is released.
Standards and methods
Results are reported against the method below, or against your buyer's specification where you send one with the sample.
Ask for the full NABL scope document if you need to confirm accredited coverage before sending the sample.
Not sure which parameters your buyer wants?
Send us the specification. We will tell you what to test and what it costs, at no charge.
The approvals this work is issued under
Held under a CDSCO drug testing licence with Good Laboratory Practice approval and NABL TC-5843 accreditation, so results stand in regulatory filings and inspections.
Before you send it
Quantity as per the monograph, typically 100 units of a solid dosage form or 25 g of API, with the certificate of analysis and the method if it is in-house.
7 to 10 working days for a monograph panel. Method validation and stability studies are scheduled against protocol.
Formulation and API manufacturers
Contract development and manufacturing organisations
Drug regulatory and quality assurance teams
Importers and distributors of finished drugs
Send a sample
Fill in the Test Request Form, pack the sample as described above and courier it to the Jaipur laboratory. Call us first if the sample is perishable.
Get the TRFRelated queries
Questions we get asked
Can you validate our in-house method?
Yes. We run validation to ICH Q2 with accuracy, precision, specificity, linearity, LOD, LOQ and robustness, and issue a validation report.
Do you run stability studies?
Yes, in ICH zone IVb conditions at 30 degrees and 75 percent relative humidity, plus accelerated at 40 and 75.
Do you accept samples against an in-house monograph?
Yes. Send the method and the specification. If it is not validated we can validate it first and report both.
How long does a nitrosamine risk assessment take?
Two to three weeks including method setup, since the confirmatory work runs at parts per billion on a dedicated method.
Can you release a batch faster than ten days?
Priority release testing on a defined panel can be done in three to five working days. Sterility and endotoxin cannot be shortened.
Request a quote
Tell us what you need tested
Send the product, the market it ships to and the standard you are being held to. Our technical team replies with the parameter list, the sample quantity we need and a firm turnaround. Quotes usually go out the same working day.
+91-9950229764 / +91-9634063932
Sample receipt: Monday to Saturday, 9:30 am to 6:00 pm