L-Histidine Base Excipient Supplier

10-07-2026

Complete Sourcing Guide for India

If you are searching for a reliable L-Histidine base excipient supplier, this guide covers what the excipient is used for, why it matters in biologics formulation, the specifications to check before ordering, and how to source it from verified manufacturers in India.

What Is L-Histidine Base

L-Histidine is an essential amino acid with CAS number 71-00-1. In pharmaceutical manufacturing, the free base form is valued for its buffering capacity and its unique side chain chemistry, which sets it apart from most other amino acid excipients. It is distinct from L-Histidine hydrochloride monohydrate, CAS 5934-29-2, which is the salt form and is often used alongside the base in buffer systems.

Histidine's side chain has a pKa of approximately 6.0, which makes it especially effective as a buffering agent in the pH 5.5 to 6.5 range. This property, combined with its ability to reduce protein aggregation and viscosity, has made it one of the more widely used excipients in modern biologics formulation.

Why Pharmaceutical Manufacturers Use L-Histidine Base

L-Histidine base is used across several areas of biopharmaceutical and pharmaceutical manufacturing:

Buffering agent for biologics. It is one of the most common buffer excipients for monoclonal antibody formulations, since its pKa aligns well with the pH range most mAb products are formulated at.
Protein stabilization. Histidine helps reduce aggregation and viscosity in high-concentration protein formulations, similar to the role arginine plays but with a distinct mechanism tied to its buffering behavior.
Antioxidant properties. It has been shown to scavenge hydroxyl radicals and singlet oxygen in solution, which supports formulation stability during storage.
Cryoprotectant and lyoprotectant. Histidine is used in freeze-dried formulations to help protect protein structure during the lyophilization process.
Combined buffer systems. It is frequently used in combination with L-Histidine hydrochloride to fine-tune buffer pH precisely, rather than using either form alone.
Nutritional and amino acid infusion formulations. Beyond biologics, it also appears in parenteral nutrition and compound amino acid preparations.

L-Histidine Base vs L-Histidine Hydrochloride

Formulation teams often use the base and hydrochloride forms together rather than choosing one over the other:

L-Histidine base (CAS 71-00-1) is the free amino acid, generally used as the primary buffering component.
L-Histidine hydrochloride monohydrate (CAS 5934-29-2) is the salt form, commonly blended with the base in a defined ratio to achieve the exact target pH of a histidine buffer system.

Since the ratio between the two directly affects buffer pH, sourcing consistent, high purity material for both forms is important for formulation reproducibility.

Specifications to Check Before You Buy

L-Histidine base sold for general industrial or nutraceutical use is not automatically suitable for pharmaceutical or biologics formulation. Before selecting a supplier, confirm:

Pharmacopoeial compliance. Look for material tested against USP, Ph. Eur., JP, or ChP monographs.
Endotoxin and bioburden limits. For parenteral and biologic applications, especially injectable mAb formulations, low endotoxin and low bioburden grade is essential.
Heavy metals and residual solvents. Confirm impurity limits are within pharmacopoeial thresholds.
Non-animal origin. Many formulators specifically require non-animal origin material for regulatory and sourcing transparency, particularly for biologics manufacturing.
Cell culture grade testing. If the material will be used in upstream processes, ask whether it has been cell culture tested.
Full documentation. Every batch should be accompanied by a Certificate of Analysis, along with SDS and TDS where available.

How to Source L-Histidine Base Excipient in India

Sourcing directly from unverified traders often means inconsistent grade, missing documentation, and no regulatory support, which is a real risk when the excipient directly affects biologic drug stability. A more dependable approach is sourcing through a platform built specifically for pharmaceutical excipients.

Clyzo is India's excipient-focused B2B marketplace, listing Histidine excipient (CAS 71-00-1) from qualified manufacturers alongside its hydrochloride counterpart. On Clyzo, you can:

Compare listings from multiple verified suppliers in one place
Request samples directly through the platform
Use Regpro to fast-track manufacturer and product regulatory qualification
Generate instant quotes and track your order through your dashboard

Steps to Source L-Histidine Base Excipient in India

Search Histidine on Clyzo and confirm the listing matches your required pharmacopoeial grade and form, base or hydrochloride.
Compare suppliers, pack sizes, and available documentation such as COA, TDS, and MSDS.
Request a sample or start a Regpro qualification if you need manufacturer and product level regulatory checks.
Request an instant quote based on your required quantity.
Place your order and track lead time through your Clyzo dashboard.

Frequently Asked Questions

What is L-Histidine base used for in pharmaceuticals?

It is primarily used as a buffering agent and stabilizer in biologic formulations, particularly monoclonal antibody products, and also in cryoprotection during freeze-drying and in parenteral nutrition formulations.

What is the difference between L-Histidine base and L-Histidine hydrochloride?

L-Histidine base, CAS 71-00-1, is the free amino acid, while L-Histidine hydrochloride monohydrate, CAS 5934-29-2, is its salt form. The two are often combined in a defined ratio to achieve a precise buffer pH.

What grade of L-Histidine should I use for biologics formulation?

Use a low endotoxin, low bioburden grade compliant with USP, Ph. Eur., JP, or ChP monographs, ideally non-animal origin and cell culture tested where relevant.

Where can I find a verified L-Histidine base supplier in India?

You can source verified, pharma grade L-Histidine base from qualified manufacturers on Clyzo, India's excipient marketplace.

Why is histidine commonly used in monoclonal antibody formulations?

Its side chain pKa of approximately 6.0 makes it an effective buffer in the pH range most mAb formulations require, while also helping reduce aggregation and viscosity.

Ready to source pharma grade L-Histidine base? Browse the listing on Clyzo and request a quote today.

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