Raw Material Identity

What Is Raw Material Identity?

Raw material identity testing verifies whether incoming material is truly the declared substance. The method is defined in the relevant pharmacopoeial monograph: comparison of the infrared spectrum with a reference, chromatographic retention-time matching, or specific identity reactions are used.

Purpose of Raw Material Identity

The purpose is to prevent the wrong substance from entering production. Good manufacturing practice (GMP) defines identity verification at raw material receipt as a fundamental requirement; this is the first line of defence for pharmaceutical safety.

Which Products Is Raw Material Identity Applied To?

Active pharmaceutical ingredient (API) shipments
Excipients
Solvents and reagents
Packaging materials (where applicable)
Intermediates

In Which Sectors Is Raw Material Identity Used?

PharmaceuticalsBiotechnologyHealthcareChemistry

Standards Related to Raw Material Identity

European Pharmacopoeia (Ph. Eur.) relevant monographs
USP <197> (spectrophotometric identification tests)
USP <1058> (analytical instrument qualification)
ICH Q2 (analytical method validation)
GMP Annex 8 (sampling of starting materials)

Raw Material Identity Conditions

Method: The identification method defined by the monograph; FTIR, NIR, HPLC or chemical reaction
Numunelendirme: As per GMP, identity is verified by every captain in the shipment
Reference: Pharmacopoeia reference standard or validated reference spectrum
Environment: Preparation protected from moisture and light-sensitive substances

Equipment for Raw Material Identity

FTIR spectrometer and ATR accessory
NIR spectrometer (for container-based rapid identity)
HPLC system
Analytical balance and sample preparation setup
Reference standard archive

Sample Requirements for Raw Material Identity

The sample must be taken so as to represent the batch or production run.
Sample description, material type, and production direction if any, must be stated.
The standard to be applied and any customer specification must be provided together with the sample.
The test may be destructive; the required number of samples must be confirmed in advance.
Surfaces that will be tested must be protected during transport.

Duration of Raw Material Identity

Container-based verification with NIR takes minutes. Chromatographic or chemical identity methods can be completed within the same working day including sample preparation.

Raw Material Identity Procedure

1The shipment is received and the sampling plan is applied.
2The identity method in the monograph is determined.
3The sample is prepared in a manner suited to the method.
4A measurement is taken (spectrum, chromatogram, or reaction observation).
5The result is compared against the reference standard or reference spectrum.
6A conformity decision is made and the batch accept/reject status is recorded.
7Results are entered into the batch file.

Raw Material Identity Acceptance Criteria

The method standard defines how the test is performed, not what the result must be. The acceptance limit comes from the material or product standard, the customer specification, or the relevant regulation; this page therefore does not give a numerical limit.

Evaluation of Results

Assessment relies on the measured spectrum or chromatogram overlapping the reference to the extent defined in the monograph. Identity is not a quantitative assay: it gives a yes/no answer to whether the substance is correct. Purity and content are determined by separate tests.

Raw Material Identity Report

Sample description, material/product information, and batch number if any
Sample preparation method and conditioning conditions
Standard and test conditions applied
Instrument used and calibration status
Measurement results and units
Measurement uncertainty (if requested)
A statement that the result applies only to the specimen submitted for testing

Accreditation

EUROLAB holds internationally recognised accreditation obtained from accreditation bodies party to the IAF and ILAC multilateral recognition arrangements, under ISO/IEC 17025 for laboratory testing, ISO/IEC 17020 for inspection and surveillance, and ISO/IEC 17021-1 and ISO/IEC 17065 for system and product certification. This chain ensures the reports and certificates issued are accepted worldwide.

Whether this test can be offered within accredited scope depends on your product and the standard applied; since accreditation is method-based, the scope is confirmed in writing at the quotation stage.

Scope and authorisations

Related Regulations

Good Manufacturing Practice (GMP) Guide
EU 2001/83/EC and related national pharmaceutical regulation
Regulation on Manufacturing Sites of Medicinal Products for Human Use

Pharmaceutical Analysis — What Does This Testing Field Cover?

The section below describes the field that the Raw Material Identity test belongs to; the conditions and acceptance criteria of this particular test are given in the sections above. The scope specific to your product is confirmed in writing at the quotation stage.

Pharmaceutical analysis determines the identity, purity, quantity and behaviour of an active substance and of the finished product. What sets this family apart is that the methods are largely defined in PHARMACOPOEIAS: the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopeia (USP) give both the method and the acceptance framework together.

The binding nature of the pharmacopoeial method shapes how the field works. In other sectors a laboratory can choose a suitable method, whereas here the method in the monograph governs; if an alternative method is to be used, its equivalence must be demonstrated. This is what makes results comparable worldwide.

Analyses are carried out in several groups. Identity and assay (HPLC, UV, titration) show what the product is and how much active substance it contains. The impurity profile and residual solvents look for unwanted compounds arising from the manufacturing process. Elemental impurities address metals originating from catalysts and equipment. Dissolution and disintegration behaviour is the most important in vitro indicator of how the drug will be released in the body.

The DISSOLUTION TEST is one of the most critical measurements in the field. It is not enough for a tablet to contain the right amount of active substance; that substance must dissolve at a suitable rate. The dissolution profile is used to assess the effect of formulation changes on bioavailability and holds a central place in generic drug licensing.

METHOD VALIDATION is a mandatory step in this family. If a pharmacopoeial method is used, it is verified that the method works properly under that laboratory's conditions. If an in-house method has been developed, it is validated against parameters such as linearity, precision, accuracy, specificity, limits of detection and quantification, and robustness. A result produced with an unvalidated method cannot be used in a licence dossier.

Stability studies determine shelf life and are the longest-running work in the field. The product is held under defined temperature and humidity conditions, analysed at set intervals, and the results become the basis of the shelf life and storage condition claims. Accelerated conditions give preliminary information but real-time data is what counts.

The microbiological side is a separate body of work: microbial enumeration, testing for specified microorganisms, sterility testing for sterile products and the bacterial endotoxin test. For sterile products, packaging integrity and sterilisation validation also come into play.

Data integrity has moved to the centre of inspections in recent years. It is not enough for the result to be correct; the raw data must be traceable, unalterable and auditable. Validation of electronic record systems has therefore become an inseparable part of analysis.

Method groups in this field

Identity and assay
HPLC, UPLC, UV-Vis spectrophotometry, titration, identity confirmation by FTIR.
Impurities and residues
Related impurities, degradation products, residual solvents (GC headspace), nitrosamine screening.
Elemental impurities
Determination of elemental impurities by ICP-MS and ICP-OES and the associated risk assessment.
Physicochemical
Dissolution and disintegration, hardness, friability, uniformity of dosage units, water content (Karl Fischer), particle size.
Microbiological
Microbial enumeration, specified microorganisms, sterility, bacterial endotoxin, preservative efficacy.
Stability
Real-time and accelerated stability studies; photostability and in-use stability.

Commonly confused in this field

The pharmacopoeial method is binding; an alternative method may be used only by demonstrating its equivalence.
A result produced without method validation cannot be used in a licence dossier.
Accelerated stability does not replace real-time data; shelf life is supported by real-time results.
The dissolution profile is sensitive to apparatus type, agitation rate and medium; the conditions must be complete in the report.
A shortcoming in data integrity produces a non-conformity in an inspection even when the result is correct.
A change of formulation or supplier requires analytical comparison and, where necessary, a new stability study.

Which decisions these results support

The licence dossier and batch release
Determining shelf life and storage conditions
Method transfer and method validation
Incoming raw material acceptance control from suppliers
Assessing the effect of a formulation change on bioequivalence

Related Tests

Frequently Asked Questions About Raw Material Identity

Why is a sample taken from every container?

GMP requires identity to be verified for every container in a shipment. A single wrong container in a pallet spoils the entire batch at the blending stage.

Is the NIR identity test sufficient?

If a validated NIR library exists, it can be used for rapid container-based identity. However, the method must be validated and justified as an alternative accepted by the monograph.