NABL Accredited CDSCO Approved BIS IS 17390:2020

Hand Sanitizer Testing | Ethanol Content | Methanol | NABL Accredited | Auriga Research

Auriga Research provides NABL-accredited hand sanitizer and skin antiseptic testing for alcohol-based hand rubs (ABHR), non-alcoholic sanitizers, surgical scrubs, and antimicrobial hand washes. Manufactured hand sanitizers in India are regulated as drugs under the Drugs and Cosmetics Act, 1940 — not as cosmetics — and must be released against the Indian Pharmacopoeia ethanol or isopropyl alcohol monographs, BIS IS 17390:2020 specification for skin antiseptic preparations, or the WHO-recommended handrub formulations published in WHO Technical Report 970 (Annex 3).

Scope covers ethanol and isopropanol assay by GC, methanol contamination screening at the 200 ppm regulatory limit, antimicrobial efficacy by EN and ASTM methods, preservative effectiveness, residual solvents, heavy metals, microbial limits, packaging compatibility, and ICH-aligned stability studies. Reports are accepted by State Drug Controllers, CDSCO, USFDA OTC submissions, Central Government tender authorities (CGHS, ESI, state procurement), and export inspection agencies.

Methanol Contamination — an Active Regulatory Concern

Methanol contamination in hand sanitizers remains an active regulatory concern — CDSCO, WHO, and USFDA have all issued guidance and continue routine surveillance and import-alert action. The maximum permissible methanol level under BIS IS 17390, IP, and USP is not more than 200 ppm (0.02 percent) in alcohol-based sanitizers. Auriga’s GC-FID headspace method quantifies methanol with a limit of detection below 50 ppm — well within the regulatory threshold.

Chemical testing 7 to 10 business days | Efficacy testing 3 to 4 weeks | PET 28 to 35 days

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Six Hand Sanitizer Testing Services

Each card maps the service to the analytical method, the governing regulatory or pharmacopoeial reference, and the deliverable.

Ethanol

Ethanol Content by GC

Ethanol assay by gas chromatography per WHO Technical Report 970 (Annex 3) and IP / USP 611. Quantifies WHO Formulation I (80 percent v/v) and Formulation II (IPA 75 percent v/v).

Methanol

Methanol & IPA Screening by GC

Methanol screening by GC-FID headspace per CDSCO and BIS IS 17390:2020 — limit not more than 200 ppm (0.02 percent). LOD below 50 ppm. Isopropanol identification and quantification in the same run.

Efficacy

Antimicrobial Efficacy Testing

Hygienic hand-rub efficacy per EN 1500 (5-log reduction E. coli K12), healthcare personnel handwash per ASTM E1174, waterless hand-rub per ASTM E2755, and virucidal methods (EN 14476, ASTM E1052).

Microbial

Microbiological Testing

Microbial limit testing per IP and USP 61 and 62, plus WHO microbial-quality requirements for handrub preparations. Total aerobic count, yeast and mould, and absence of specified pathogens.

Physical

Viscosity & Physical Characteristics

Viscosity, pH, specific gravity, appearance, colour, glycerol content, and hydrogen peroxide content (WHO formulations). Physical-attribute testing for gel and liquid form factors.

PET / ICH

Preservative Content & Stability Testing

Preservative efficacy test (PET) per USP 51, preservative content quantification, and ICH Q1A(R2) accelerated (6 months) and long-term (12 to 24 months) stability for shelf-life support.

Test Parameters in Scope

Chemical & Quality

Ethanol / isopropanol content (% v/v)
Methanol content (limit: 200 ppm)
Identification of active ingredient
pH
Specific gravity / density
Appearance, colour, viscosity
Glycerol content (WHO formulations)
Hydrogen peroxide content (WHO formulations)
Acetaldehyde, acetone (denaturant residues)
Residual solvents per USP 467
Heavy metals (Pb, As, Hg, Cd) by ICP-MS
Benzene impurity per CDSCO / USFDA

Microbial & Efficacy

Microbial limits per USP 61 / IP
Tests for specified microorganisms USP 62
Preservative efficacy (PET) per USP 51
EN 1500 — hygienic hand-rub efficacy
EN 1276 — bactericidal suspension test
EN 13727 — bactericidal activity (medical)
EN 14476 — virucidal activity
ASTM E1174 — healthcare personnel handwash
ASTM E2755 — waterless hand-rub on hands
ASTM E1052 — virucidal suspension method
Log-reduction studies on custom organisms
Time-kill kinetics

Specialty add-ons: chlorhexidine / triclosan / benzalkonium chloride / povidone-iodine content for non-alcoholic and combination antiseptics.

Project Timelines

Indicative TAT from sample receipt. Confirm exact timeline with your SPOC at quote stage based on test scope and sample queue.

Service Type	Turnaround Time
Chemical Testing (assay, methanol, pH, density, residual solvents)	7 to 10 business days
Microbial Limit Testing (IP / USP 61 / 62)	7 to 10 business days
Antimicrobial Efficacy (EN 1500, ASTM E1174, E2755)	3 to 4 weeks
Preservative Efficacy Test (USP 51)	28 to 35 days
ICH-Aligned Accelerated Stability	6 months
ICH-Aligned Long-term Stability	12 to 24 months

How It Works

Get a Quote

Share your formulation type (ethanol or isopropanol) and regulatory requirement (CDSCO registration, export, or routine QC). Your SPOC confirms applicable tests.

Collect and Send Your Sample

Prepare sample per SPOC instructions at quote stage. Each sample is bar coded and registered in YLIMS on receipt.

Testing and QA Review

Your sample is tested under NABL-accredited conditions. Results pass through formal QA review including instrument log check, reference standard verification, and analyst sign-off.

Receive Your NABL Report

Your NABL-accredited report is delivered digitally within the committed TAT, formatted for CDSCO, USFDA, and regulatory submission. Track status via YLIMS.

Who Needs Hand Sanitizer Testing

Hand sanitizer manufacturers requiring CDSCO drug-manufacturing-licence (Form 25 / Form 28) registration testing.
Private-label brands launching hand sanitizer products under retail or e-commerce contract manufacturing.
Exporters requiring WHO Technical Report 970 or EN-standard compliance evidence for international buyers.
QC teams inspecting ethanol or isopropanol raw-material batches before manufacturing release.
Healthcare and surgical antiseptic manufacturers needing EN 1500, EN 13727, EN 14476, and ASTM E1174 efficacy data.
Government tender bidders (CGHS, ESI, Defence, state health departments) requiring NABL release certificates.
Retail platforms (Amazon, Flipkart, modern trade) running brand-assurance and counterfeit audits on listed SKUs.
Post-market complaint investigators and forensic teams analysing suspected adulterated or sub-standard product.

Why Auriga for Hand Sanitizer Testing

GC-MS + GC-Headspace for Ethanol & Methanol

Accurate ethanol and methanol quantification by GC-MS and GC-headspace with LOD below 50 ppm for methanol — well below the 200 ppm regulatory threshold under BIS IS 17390, IP, and USP.

NABL Reports Accepted by CDSCO

NABL accredited (ISO/IEC 17025:2017) reports accepted by State Drug Controllers, CDSCO drug-licence applications (Form 25 / Form 28), USFDA OTC monograph submissions, and EU Biocidal Products Regulation filings.

Complete Testing Package from One Lab

Chemical, microbial, antimicrobial efficacy (EN + ASTM), preservative efficacy, and ICH stability — all under one NABL scope. One sample submission, one consolidated NABL report.

BIS IS 17390:2020 Conformity Coverage

Conformity testing against the current Indian Standard for skin antiseptic preparation in liquid and gel form. Required for retail and institutional procurement tenders.

WHO Technical Report 970 Formulations

Verification testing for WHO Formulation I (ethanol 80 percent v/v) and Formulation II (isopropanol 75 percent v/v) for healthcare-establishment in-house production programmes.

Tender and Export Documentation Support

Documentation packs ready for CGHS, ESI, Defence, state procurement tenders, USFDA OTC, and EU Biocidal Products Regulation (PT1) submissions.

NABL Accredited Labs

5 Cities

Delhi · Manesar · Bahadurgarh · Baddi · Bangalore

12,000+

Clients Served

1985

Arbro Group · Auriga Research

Standards & Methods

IP — Indian Pharmacopoeia ethanol and isopropyl alcohol monographs
USP — Alcohol determination 611, Residual Solvents 467, Antimicrobial Effectiveness 51, Microbial Limits 61 / 62
BP / EP — equivalent monographs for ethanol, isopropyl alcohol, and antiseptic preparations
BIS IS 17390:2020 — Indian Standard for skin antiseptic preparation (liquid and gel form)
BIS IS 2638 — Ethanol specification
WHO Technical Report 970 (Annex 3) — WHO-Recommended Handrub Formulations (Formulation I and II)
CDSCO Drugs and Cosmetics Rules 1945 — manufacture, labelling, and quality requirements
EN 1500, EN 1276, EN 13727, EN 14476 — European bactericidal and virucidal efficacy
ASTM E1174, E2755, E1052 — US healthcare hand antisepsis methods
ICH Q1A(R2) — accelerated and long-term stability studies

Product Types Accepted

Alcohol-based hand rubs (ABHR) — ethanol and isopropanol formulations, gel and liquid
WHO Formulation I (ethanol 80 percent v/v) and Formulation II (isopropanol 75 percent v/v)
Surgical hand scrubs and pre-operative skin antiseptics
Healthcare-personnel hand washes and hand rubs
Chlorhexidine gluconate solutions, povidone-iodine antiseptics
Quaternary-ammonium and benzalkonium-chloride based sanitizers
Combination antiseptics (alcohol + chlorhexidine, alcohol + emollient)
Food-grade sanitizers used in food handling environments
Foam sanitizers, spray sanitizers, wipes, and wet tissues
Branded retail SKUs and bulk industrial sanitizers
Raw materials — ethanol, isopropanol, glycerol, hydrogen peroxide

Applications

CDSCO drug-manufacturing-licence (Form 25 / Form 28) submissions
BIS IS 17390:2020 conformity assessment for retail and institutional procurement
Government tenders — CGHS, ESI, Defence, state health and procurement bodies
USFDA OTC monograph compliance and import alert defence
EU export documentation under Biocidal Products Regulation (PT1)
WHO-formulation verification for healthcare-establishment in-house production
New product development and reformulation for hand sanitizer ranges
Retailer due-diligence audits (Amazon, Flipkart, modern trade brand assurance)
Counterfeit / spurious product investigation and forensic testing
Post-market surveillance and quality complaint investigations

Related Resources

Frequently Asked Questions

Is a hand sanitizer regulated as a drug or a cosmetic in India?

Alcohol-based hand sanitizers (ABHS) are regulated as drugs in India under the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945. Manufacture requires a drug-manufacturing licence from the State Drug Controller, and products must comply with the relevant pharmacopoeial monograph (IP, USP, or BP) or with BIS IS 17390:2020 — the Indian Standard for skin antiseptic preparations in liquid and gel form. They are not classified as cosmetics under the Cosmetics Rules 2020. Non-alcohol-based skin cleansers without antimicrobial claims may fall under cosmetics, but anything making an antimicrobial / antiseptic / antiviral claim is a drug.

Why is methanol testing critical for hand sanitizers?

Methanol contamination in hand sanitizers remains an active regulatory concern. CDSCO surveillance, WHO guidance, and USFDA import alert coverage are all active and ongoing. Methanol is toxic on dermal absorption and can be lethal if ingested. The acceptable limit under BIS IS 17390, IP, and USP is not more than 200 ppm (0.02 percent) of methanol in alcohol-based sanitizers. Auriga quantifies methanol by GC-FID with headspace sampling against deuterated internal standards, with limit of detection well below 50 ppm.

What antimicrobial efficacy tests do you perform on hand sanitizers?

Auriga performs the full suite of efficacy methods accepted under Indian, European, and US frameworks: EN 1500 (hygienic hand-rub efficacy against E. coli K12 with 5-log reduction within 30 to 60 seconds), EN 13727 (bactericidal activity for medical use), EN 14476 (virucidal activity including SARS-CoV-2 surrogates), EN 1276 (bactericidal suspension test), ASTM E1174 (healthcare personnel handwash), ASTM E2755 (waterless hand-rub on hands), and ASTM E1052 (suspension method for virucidal activity). Log-reduction studies against custom challenge organisms are also available.

Which monographs and standards do you test against?

Reference frameworks are IP (Indian Pharmacopoeia) Ethanol and Isopropyl Alcohol monographs, USP general chapters 611 (alcohol determination), 467 (residual solvents), 51 (antimicrobial effectiveness), 61 (microbial limits), 62 (tests for specified microorganisms), BIS IS 17390:2020 specification for skin antiseptic preparation, BIS IS 2638 ethanol specification, and the WHO Guide to Local Production: WHO-Recommended Handrub Formulations (Formulation I — ethanol 80 percent v/v and Formulation II — isopropyl alcohol 75 percent v/v with glycerol and hydrogen peroxide). Reports cite the exact method against which each parameter was tested.

How long does hand sanitizer testing take?

Chemical testing — alcohol content, methanol, identification, pH, density, residual solvents — is reported within 7 to 10 working days of sample receipt. Microbial limit testing adds 7 to 10 working days. Antimicrobial efficacy testing (EN 1500, ASTM E1174, ASTM E2755) requires 3 to 4 weeks for in vitro studies; expanded protocols (multi-organism panels, time-kill kinetics) run 5 to 6 weeks. Preservative efficacy testing (USP 51) takes 28 to 35 days. ICH-aligned accelerated stability is 6 months; long-term is 12 to 24 months. Expedited reporting is available for time-critical regulatory submissions.

Do you support CDSCO drug-manufacturing-licence applications and export documentation?

Yes. Auriga reports are accepted by State Drug Controllers and CDSCO for drug-manufacturing-licence (Form 25 / Form 28) applications, renewals, and product approvals. For exports, reports are aligned with USFDA OTC monograph requirements, EU Biocidal Products Regulation (PT1) submissions, and country-specific health authority dossiers. Scope includes the analytical, microbiological, and efficacy data required for regulatory submissions and procurement tenders (CGHS, ESI, state health departments).

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