NABL CDSCO ICH Q6A XRD at Baddi — Xcelerator Detector

XRD Pharmaceutical Testing | Polymorph Identification | NABL Accredited | Auriga Research

Powder X-Ray Diffraction at our Baddi laboratory with PANalytical Xcelerator detector — polymorph identification per ICH Q6A, crystallinity determination, ICDD PDF-4+ phase matching and asbestos screening in pharmaceutical talc per USP <901>.

X-Ray Diffraction (XRD) is the definitive analytical technique for determining the crystallographic structure and polymorphic identity of pharmaceutical substances. Auriga Research operates an NABL-accredited powder XRD platform at the Baddi laboratory (Himachal Pradesh — adjacent to the pharma manufacturing cluster) equipped with a PANalytical Xcelerator high-speed strip detector for rapid phase identification, polymorph screening, crystallinity determination and asbestos detection in pharmaceutical talc.

In pharmaceutical development, XRD testing serves as the primary tool for polymorphism screening per ICH Q6A — identifying all crystalline forms a drug substance can adopt. Each polymorph produces a unique diffraction fingerprint, enabling unambiguous form identification, batch-to-batch consistency verification and detection of unintended polymorphic conversions during processing or storage. Phase assignments are made against the ICDD PDF-4+ database, the standard reference database for pharmaceutical powder XRD work — Auriga does not rely on the Cambridge Structural Database (CSD), which is a small-molecule crystallographic research tool and not the appropriate reference for routine pharma PXRD.

Beyond polymorphism, our XRD capabilities at Baddi include amorphous content quantification, asbestos screening in pharmaceutical talc per USP <901>, crystal form stability assessment during ICH Q1A(R2) studies and ICDD PDF-4+ phase identification of excipients and APIs. Combined with DSC and TGA at our USFDA Inspected Manesar facility and FTIR at Delhi, Baddi and Bangalore, XRD at Baddi delivers the comprehensive solid-state characterisation package required for CTD Module 3.2.S.3.1 (Elucidation of Structure) submissions worldwide.

XRD Equipment at Baddi

PANalytical X-Ray Diffractometer with Xcelerator detector at Auriga Research Baddi laboratory — NABL accredited polymorph and crystallinity testing

Auriga Research operates a research-grade powder X-Ray Diffractometer at the Baddi laboratory equipped with a PANalytical Xcelerator high-speed strip detector. The platform supports polymorph identification, crystallinity determination, phase identification by ICDD PDF-4+ matching, asbestos screening in pharmaceutical talc per USP <901> and crystal form stability assessment during ICH Q1A(R2) studies.

Lab location:
Auriga Baddi (Himachal Pradesh)
Detector:
PANalytical Xcelerator (high-speed strip)
Technique:
Powder X-Ray Diffraction (PXRD)
Reference database:
ICDD PDF-4+
Pharmacopoeial / ICH coverage:
USP <941> X-Ray Powder Diffraction · USP <901> Asbestos in Pharmaceutical Talc · ICH Q6A polymorph specifications
Accreditation:
NABL ISO/IEC 17025:2017

Specific diffractometer make and model confirmation pending lab team sign-off; the Xcelerator detector and ICDD PDF-4+ reference database are confirmed and in active use today for all listed pharmacopoeial and ICH services under NABL accreditation.

XRD Testing Services

Each service mapped to its ICH or USP reference for quick CTD Module 3 scoping.

Polymorph

Polymorph Identification & Screening

Polymorphic form identification and screening per ICH Q6A — performed on the Baddi XRD platform with Xcelerator detector for rapid pattern acquisition.

Crystallinity

Crystallinity Determination

Crystallinity determination — amorphous vs crystalline ratio per ICH Q6A for APIs, excipients, solid dispersions and spray-dried intermediates.

PDF-4+

Phase ID by ICDD PDF-4+ Matching

Phase identification by PXRD with ICDD PDF-4+ database matching — the standard pharmaceutical XRD reference database for unambiguous polymorph and excipient assignment.

USP <901>

Asbestos Detection in Pharma Talc

Asbestos screening in pharmaceutical talc per USP <901> — chrysotile, amphibole and tremolite peak identification against ICDD reference patterns at our Baddi lab.

Stability

Crystal Form Stability Assessment

Crystal form stability assessment during ICH Q1A(R2) stability studies — XRD overlay at each time point to detect form conversion, hydrate transitions or amorphous collapse.

Solid State

XRD in Solid-State Package

XRD delivered as part of a complete solid-state characterisation package alongside DSC and TGA at Manesar and FTIR at three labs — single SPOC, single NABL report.

How It Works — 4 Steps to Your NABL XRD Report

1

Get a Quote

Share compound, development stage and crystallography question — polymorph identification, asbestos detection or full solid-state package. Your SPOC confirms scan range, step size and sample requirement.

2

Collect and Send Your Sample

Prepare per SPOC instructions at quote stage. Each sample is bar-coded and registered in YLIMS on receipt with full chain-of-custody.

3

Testing and QA Review

Tested under NABL-accredited conditions at our Baddi XRD facility. Results pass through formal QA review before release.

4

Receive Your NABL Report

NABL report delivered digitally within committed TAT, formatted for CDSCO, USFDA and regulatory submission. Track via YLIMS.

Project Timelines

Package Turnaround Time
Standard XRD Analysis (phase ID, polymorph confirmation) 5-7 business days
Rush XRD Analysis 2-3 business days
Polymorph Screening Programme (multiple samples) 7-14 business days
Asbestos in Talc per USP <901> 5-7 business days
Full Solid-State Package (XRD + DSC + TGA + FTIR) 10-14 business days

Who Needs XRD Pharmaceutical Testing

  • ✓ Pharma manufacturers requiring polymorph data for CDSCO or USFDA dossier submission
  • ✓ Generic developers selecting the optimal crystal form during API development
  • ✓ Talc-containing product manufacturers requiring asbestos screening per USP <901>
  • ✓ Stability teams monitoring solid-state changes during ICH Q1A(R2) accelerated and long-term stability
  • ✓ Patent and IP teams gathering crystallographic data for polymorphic form claims
  • ✓ CDMO clients ordering XRD as part of a full solid-state characterisation package
  • ✓ API manufacturers documenting batch-to-batch crystallographic consistency for DMF filings
  • ✓ Regulatory affairs teams compiling CTD Module 3.2.S.3.1 (Elucidation of Structure) packages

Why Auriga for XRD Testing

Xcelerator Detector at Baddi

Powder XRD at Baddi with PANalytical Xcelerator high-speed strip detector — rapid polymorph screening and high-throughput pattern acquisition for development-stage workloads.

Non-Destructive Technique

XRD is non-destructive — your sample is recoverable for further testing on DSC, TGA, FTIR or HPLC after the diffraction run. Particularly valuable for limited drug-substance inventories.

XRD + DSC + TGA + FTIR Under One Roof

XRD at Baddi alongside DSC and TGA at Manesar (USFDA Inspected) and FTIR at Delhi, Baddi and Bangalore — complete solid-state characterisation in one organisation with one SPOC and one NABL report.

ICDD PDF-4+ Database Matching

Phase assignment against the ICDD PDF-4+ database — the standard pharmaceutical XRD reference database. Eliminates the false-positive risk of generic open-data matching.

USP <901> Asbestos Screening

Talc asbestos screening per USP <901> performed on the same Baddi XRD platform — pharmaceutical and cosmetic talc release in one place.

Bar-Coded YLIMS Chain of Custody

Every sample is bar-coded and registered in YLIMS on receipt — full audit trail from logbook to report download with NABL-accredited QA review before release.

5+

NABL Labs

5 Cities

Delhi · Manesar · Bahadurgarh · Baddi · Bangalore

12,000+

Clients Served

1985

Arbro Group Established

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Frequently Asked Questions — XRD Pharmaceutical Testing

What is XRD analysis and what does it measure?
XRD (X-Ray Diffraction) analysis is a technique that determines the crystallographic structure, phase composition and crystallinity of materials by directing X-rays at a sample and measuring the diffraction pattern. In pharmaceutical applications, XRD identifies polymorphic forms per ICH Q6A, distinguishes crystalline from amorphous content, confirms crystal structure identity, and quantifies mixtures of polymorphic phases. Each crystalline form produces a unique diffraction pattern that serves as a fingerprint for identification.
Where is the Auriga XRD instrument located?
Auriga Research operates its powder X-Ray Diffractometer at the Baddi laboratory (Himachal Pradesh — adjacent to the pharma manufacturing cluster). The instrument is equipped with a PANalytical Xcelerator high-speed strip detector for rapid polymorph screening and routine phase identification on pharmaceutical APIs, excipients and talc-containing products. XRD at Baddi sits alongside DSC and TGA at Manesar (USFDA Inspected) and FTIR at Delhi, Baddi and Bangalore so customers can commission a complete solid-state characterisation package (XRD + DSC + TGA + FTIR) from one organisation under one NABL report.
How does XRD testing support pharmaceutical polymorphism studies?
XRD is the definitive technique for polymorphic form identification because each polymorph has a unique crystal structure that produces a distinct diffraction pattern. XRD testing supports polymorph screening per ICH Q6A, form identification during process development, batch-to-batch consistency checks, patent support with crystallographic data and regulatory submissions requiring solid-state characterisation in CTD Module 3.2.S.3.1. Phase assignments are made against the ICDD PDF-4+ database — the standard reference database for pharmaceutical powder XRD work. Combined with DSC and TGA at Manesar, XRD at Baddi provides complete polymorphic characterisation.
Can Auriga screen pharmaceutical talc for asbestos by XRD per USP <901>?
Yes. XRD at Baddi is used for asbestos screening in pharmaceutical talc per USP <901>. The test identifies the chrysotile, amphibole and tremolite asbestiform peaks against ICDD PDF-4+ reference patterns. Pharmaceutical talc-containing product manufacturers — particularly those filing with CDSCO or USFDA — routinely commission this screening as part of incoming raw material release.
What is the minimum sample quantity required for powder XRD?
For routine powder X-Ray Diffraction (PXRD) at Auriga Research, we typically require 50 to 200 mg of sample. The exact quantity depends on the crystallinity of the material and the required sensitivity: 50-100 mg is sufficient for highly crystalline APIs and excipients where phase identification is the primary goal, 100-200 mg is recommended for low-crystallinity or amorphous-rich samples and for quantitative phase analysis (Rietveld) or amorphous content quantification, and as little as 10-20 mg can be analysed using a low-volume sample holder when material is precious — at the cost of slightly higher counting times and reduced statistics. Send the largest quantity that is practical; we return unused material on request.
Can Auriga perform comparative XRD against a client-supplied reference standard or in-house polymorphic form library?
Yes. Comparative XRD is one of the most common assignments we handle. Workflows include: (a) direct overlay against a client-supplied reference standard (working standard or reference polymorph) — useful for batch-to-batch consistency, incoming-material release and counterfeit identification; (b) matching against an Auriga-curated polymorphic form library of the API — useful when the client cannot supply every reference form and we have previously characterised the form; (c) ICDD PDF-4+ database matching when neither client nor in-house reference is available — useful for excipient identification and known-API phase assignment. We report quantitative pattern similarity, peak-position differences and any unique peaks indicating a different form or impurity phase. Reference patterns supplied by clients are returned with the final report and can be retained for future batch comparison on request.
What is the turnaround time for XRD testing?
Standard XRD testing at Auriga Research is completed within 5-7 business days from sample receipt. Polymorph screening programmes with multiple samples require 7-14 business days. Rush XRD analysis is available within 2-3 business days for urgent characterisation needs. The full solid-state package (XRD at Baddi + DSC and TGA at Manesar + FTIR at Delhi/Baddi/Bangalore) is delivered within 10-14 business days.

Need XRD Analysis for Your Pharmaceutical Samples?

NABL-accredited powder X-Ray Diffraction at our Baddi lab with PANalytical Xcelerator detector. Polymorph identification, ICDD PDF-4+ phase matching and USP <901> asbestos screening with 5-7 day turnaround.

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