NABL Accredited · USP Apparatus I-IV

Dissolution Testing Laboratory India | NABL Accredited | USP Apparatus I-IV

Auriga Research performs NABL-accredited dissolution testing for pharmaceutical solid dosage forms using validated USP apparatus and regulatory-ready reporting for batch release, formulation development, and comparability studies.

Dissolution testing measures the rate and extent to which the active pharmaceutical ingredient is released from a dosage form into solution. It is a critical quality control measure for tablets, capsules, and other oral solid dosage forms, and a key regulatory requirement for batch release, bioequivalence support, and product development.

At Auriga Research, our pharmaceutical dissolution laboratory is equipped with qualified USP apparatus I, II, III, and IV. We can run pharmacopoeial monographs, client-specific dissolution protocols, and profile comparison studies with HPLC or UV quantification as required by the product and regulatory region.

Our method package includes method suitability verification, validated dissolution media, sample handling controls, and full audit-trail documentation. The resulting dissolution reports are accepted by CDSCO and other regulatory authorities when submitted as part of QC release documentation, stability studies, or regulatory filings.

Dissolution Testing Capabilities

Each capability is mapped to its USP apparatus or analytical output for quick regulatory matching across IR, DR, and MR products.

USP I/II

Basket & Paddle Apparatus

USP apparatus I (basket) and II (paddle) for immediate-release and delayed-release tablets and capsules.

USP III

Reciprocating Cylinder

USP apparatus III (reciprocating cylinder) for modified-release and multiparticulate products.

USP IV

Flow-Through Cell

USP apparatus IV (flow-through cell) for poorly soluble APIs and extended-release systems.

Media

Media & Sampling Controls

Validated media preparation and dissolution sampling under controlled temperature and stirring.

HPLC / UV

Quantification

HPLC and UV quantification of dissolved drug concentrations across the sampling profile.

f2

f2 Profile Comparison

Dissolution profile comparison using the USP f2 similarity factor for generic comparability.

Batch QC

Batch Release Testing

Batch release and QC testing for routine commercial production with audit-trail reporting.

Stability

Stability-Indicating Dissolution

Stability-indicating dissolution studies for post-approval changes and shelf-life support.

Transfer

Method Transfer & Validation

Method transfer, verification, and protocol validation for regulatory submissions.

Typical Dissolution Testing Turnaround

Standard Dissolution Testing: 7-10 business days
Rush Dissolution Testing: 3-5 business days
Profile Comparison and f2 Analysis: 7-10 business days
Method Transfer / Validation Support: 2-3 weeks

Who Should Choose Auriga for Dissolution Testing

  • ✓ Generic drug manufacturers requiring batch release testing per pharmacopeial monographs
  • ✓ Formulation development teams validating immediate-release and modified-release products
  • ✓ Companies performing comparability studies after formulation, site, or process changes
  • ✓ Exporters needing regulatory-ready dissolution reports for CDSCO, USFDA, and international submissions
  • ✓ Pharma suppliers seeking USP apparatus IV testing for low-solubility dosage forms

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Frequently Asked Questions — Dissolution Testing

What dissolution apparatus does Auriga Research use?
Auriga Research operates qualified USP apparatus I (basket), II (paddle), III (reciprocating cylinder), and IV (flow-through cell) to meet pharmacopoeial monographs and client-specific release protocols for tablets, capsules, suspensions, and modified-release forms.
Can you perform dissolution profile comparison using f2 similarity?
Yes. We perform dissolution profile comparison using the USP f2 similarity factor and other statistical approaches as required by generic product development, regulatory comparability studies, and formulation optimisation.
Do you support dissolution testing for regulatory batch release?
Yes. Auriga Research provides NABL-accredited dissolution testing for batch release and QC release documentation. We can run routine pharmacopoeial methods, product-specific protocol conditions, and stability-indicating dissolution methods with validated instrumentation and complete audit trail reporting.
Which dosage forms do you test for dissolution?
We test immediate-release and modified-release tablets, hard and soft gelatin capsules, oral dispersible tablets, chewable tablets, suspensions, and other oral solid dosage forms using the correct apparatus, dissolution media, and sampling schedule for each product type.

Need Dissolution Testing for Your Pharmaceutical Product?

NABL-accredited dissolution testing with USP apparatus I-IV and regulatory-ready reporting for CDSCO and international submissions.

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