Drug Impurity Reference Standards for HPLC

Drug Impurity Reference Standards

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Drug Impurity Reference Standards for
Pharmaceutical Quality Control and Regulatory Compliance

- Certified drug impurity reference standards for HPLC, LC-MS, and stability testing. Ensure traceability, accuracy, and compliance with USP, EP, and ICH guidelines for pharmaceutical development and production.

At uHPLCs, we specialize in high-purity Drug Impurity Reference Standards designed to meet the strict demands of pharmaceutical quality control, stability testing, and regulatory compliance.
Our portfolio includes identified impurities, degradation products, process-related impurities, and residual solvents across a wide range of APIs and finished formulations.

Each impurity standard comes with a Certificate of Analysis (CoA) and comprehensive documentation, ensuring full traceability under USP, EP, and ICH Q3A/Q3B guidelines.
Whether you are performing HPLC/LC-MS analysis, method validation, or stability studies, uHPLCs provides the accuracy, consistency, and reliability you need to maintain product integrity and meet global regulatory requirements.

We provide a wide selection of reference standards, including:

Sugar Standards – for carbohydrate analysis and food research
Vitamin Standards – supporting nutritional, pharmaceutical, and clinical testing
Amino Acid Standards – ensuring precision in protein and biochemical studies
Fatty Acid Standards – essential for lipid and metabolic analysis
Drug Impurity Standards – reliable tools for pharmaceutical quality control
Industrial Reference Standards – tailored to chemical and material industries
Food Reference Standards – supporting safety, labeling, and compliance testing
Antioxidant Standards – critical for food, cosmetic, and pharmaceutical research

In addition, we also offer custom preparation services to meet unique project needs, ensuring every reference standard delivers dependable performance.

Drug Impurity Reference Standards

Albendazol
Florfenicol
Levamisole Hydrochloride
Praziquantel
Moxidectin
Sodium citrate
Cortisone acetate
Doxycycline Hydrochloride
Clemastine Fumarate
Procaine hydrochloride

Magnesium L-aspartate
Calcium gluconate
Butafosfan
Adenosine 5’-triphosphate disodium salt
Uridine 5'-triphosphate trisodium salt（UTP-Na3）
Glutathione（G-SH）

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Preparation of Reference Standards

Get Expert Guidance and Customized Solutions for Accurate Reference Standards

uHPLCs provides a comprehensive portfolio of reference standards, covering:

Sugars & Carbohydrates (e.g., Glucose, Lactose, Raffinose)
Vitamins (A, B-series, C, D, E, K, etc.)
Amino Acids (standard & derivatives)
Fatty Acids (C14:0, C16:0, C18:0, etc.)
Pharmaceutical Impurities & Metabolites

This wide coverage reduces the need to source from multiple suppliers, ensuring consistency, reliability, and efficiency for laboratories and research facilities.

All standards are supplied with accurate molecular formula data, CAS numbers, and specifications.
Many products come with high purity levels (HPLC ≥ 98–99%) and batch traceability, supporting regulatory compliance in pharmaceuticals, food safety, and chemical analysis.
This ensures that your analytical testing results are precise, repeatable, and internationally credible.

Multiple pack sizes (mg to g scale) to match both R&D and production testing needs.
OEM & custom preparation available for specific reference standards not commonly listed.
Competitive pricing and direct factory supply provide cost-effective solutions without compromising quality.

This flexibility makes uHPLCs an ideal partner for academic labs, pharmaceutical companies, and industrial QC teams.

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Reference Standards

Laboratory staff

Low MOQ

Equipment

Customize Reference Standards Service

At uHPLCs, we understand that every laboratory, research project, and industrial application may require unique reference standards beyond standard catalogs. That’s why we provide a tailored Custom Reference Standards Service designed to meet your specific analytical and regulatory needs.

What We Offer

Custom Synthesis – Preparation of reference standards that are not commercially available or require specific modifications.
Flexible Packaging – From milligram-level for research to gram-level for industrial QC testing.
Wide Coverage – Carbohydrates, vitamins, amino acids, fatty acids, pharmaceutical impurities, and more.
High Purity & Documentation – Delivered with COA, CAS data, molecular structure, and full traceability.

Why Choose uHPLCs Custom Service?

One-Stop Solution – Save time and resources by sourcing customized standards directly from a specialized manufacturer.
Expert Technical Support – Our experienced chemists and engineers ensure accurate synthesis and verification.
Fast Turnaround & Competitive Pricing – Reliable delivery with cost-effective solutions compared to global suppliers.
OEM & Confidential Service – We also provide OEM preparation with strict confidentiality to protect your intellectual property.

What
Clients Say

uHPLCs impurity standards are essential for our routine QC and stability testing. Their detailed CoAs and traceability documents helped us pass our last FDA audit with zero observations.

QC DirectorGlobalPharma Inc.

Our CRO depends on uHPLCs for custom impurity blends during method development projects. Their team delivers exactly what we need, on time and fully compliant with ICH Q3A/B.

Principal ScientistBioTech Labs

The documentation package provided by uHPLCs streamlined our NDA submission to the EMA. Their team understands regulatory requirements deeply.

Regulatory Affairs ManagerMedixCorp

We ship globally and rely on uHPLCs’ cold-chain logistics to ensure our impurity standards remain stable during transit. They’ve never failed us.

Supply Chain ManagerVitaHealth Corp

Frequently Asked Questions

As Follow is Some Frequently Questions People Asked

1. What are Drug Impurity Reference Standards and why are they critical?

Drug Impurity Reference Standards are high-purity, certified compounds used to identify, quantify, and control impurities in pharmaceutical products.
They are essential because:

Regulatory Compliance: Required by FDA, EMA, and ICH to ensure patient safety.
Quality Control: Detect and quantify impurities during production.
Stability Testing: Identify degradation products over the product lifecycle.
Risk Reduction: Prevent recalls and ensure consistent batch quality.

Impurity Type	Example	Source
Degradation Products	Hydrolysis of Vitamin C → Dehydroascorbic Acid	Storage instability
Process-Related	Synthetic by-products	Manufacturing
Genotoxic Impurities	Nitrosamines (NDMA, NDEA)	Contamination

2. Which industries use drug impurity standards?

Drug impurity standards are primarily used by:

Pharmaceutical Manufacturers: QC labs for raw material and final drug release.
Third-Party Testing Labs: Independent validation for regulatory submissions.
Contract Research Organizations (CROs): Method development and stability testing.
Regulatory Agencies: Verification of pharmaceutical submissions.

Industry	Application
Pharma Manufacturing	Batch release testing
CRO	Bioequivalence and impurity profiling
Food & Nutraceuticals	Ingredient contamination screening
Academic Research	Development of new analytical methods

3. What are the regulatory guidelines for drug impurities?

The International Council for Harmonisation (ICH) provides global standards for impurity control:

ICH Q3A: Impurities in new drug substances (APIs).
ICH Q3B: Impurities in new drug products.
ICH M7: Assessment and control of genotoxic impurities.

Region	Regulatory Agency	Standard
USA	FDA	USP <1086>, ICH Q3A/B
Europe	EMA	EP Monographs
Japan	PMDA	JP Standards

4. What documentation comes with impurity standards?

Each uHPLCs Drug Impurity Reference Standard is shipped with:

Certificate of Analysis (CoA): Purity, lot number, expiration date, and analytical method.
Material Safety Data Sheet (MSDS): Handling and storage safety.
Batch Records: Full traceability for GMP and ISO audits.
Stability Information: Recommended storage and shelf life.

5. How do drug impurity standards support pharmaceutical audits?

During FDA or EMA inspections, auditors check impurity control procedures:

Proof of traceability for every batch of standard used.
Method validation data linked to certified reference standards.
Stability testing records showing impurity trends over time.
GMP compliance for manufacturing and QC labs.

Using certified standards like uHPLCs ensures smooth audit outcomes.

6. How should drug impurity standards be stored?

Proper storage is critical to maintain integrity:

Temperature:
- Most standards: 2–8°C refrigerated
- Sensitive genotoxic impurities: -20°C freezer
Light Protection:
- Amber glass vials or foil wrapping for light-sensitive compounds.
Humidity Control:
- Store in desiccators or sealed containers.

Condition	Risk if Improper	Solution
Heat	Accelerated degradation	Cold-chain shipping
UV Exposure	Chemical breakdown	Amber vials
Moisture	Contamination	Desiccant storage

7. What analytical methods use drug impurity standards?

Drug impurity standards are compatible with:

HPLC (High-Performance Liquid Chromatography) – Routine impurity testing.
LC-MS / LC-MS/MS – Identification of trace-level impurities.
GC-MS – Volatile impurity analysis like residual solvents.
UV/IR Spectroscopy – Initial purity screening.

Method	Typical Use
HPLC	Routine QC for known impurities
LC-MS/MS	Genotoxic impurity detection
GC-MS	Residual solvent analysis
UV-Vis	Rapid screening

8. Difference between identified and unidentified impurities?

Category	Definition	Example
Identified Impurities	Chemical structure fully characterized	Process by-product with known synthesis pathway
Unidentified Impurities	Unknown structure requiring further analysis	Degradation peak discovered during stability study

Identified impurities are controlled with set limits, while unidentified impurities require investigation and method development.

9. How do impurity standards help prevent recalls?

Drug recalls often occur due to uncontrolled impurities such as nitrosamines (NDMA).
By using certified impurity standards:

Impurities are detected early in the manufacturing process.
Accurate quantification prevents non-compliant batches.
Documentation provides evidence of proactive risk management.

Result: Reduced financial loss and protection of patient safety.

Identified impurities are controlled with set limits, while unidentified impurities require investigation and method development.

10. Why choose uHPLCs for drug impurity standards?

uHPLCs provides global pharmaceutical clients with:

Comprehensive Range: Identified impurities, degradation products, genotoxic standards.
Strict Compliance: Traceable to USP, EP, and ICH guidelines.
Custom Preparation: Tailored impurity blends for specific projects.
Technical Support: Documentation assistance for regulatory submissions.
Cold-Chain Logistics: Ensure integrity during global shipping.