2% Chlorhexidine Gluconate Solution

2% Chlorhexidine Gluconate Solution: What the Published Guidance Says

Infection-prevention consumables and single-use medical devices supplied alongside our pharmaceutical range, so a programme can source the medicine and the means to deliver it safely from one supplier.

2% Chlorhexidine Gluconate Solution is specified against its own monograph, pack size and market registration, so the guidance below is worth reading together with the Devices & Antisepsis range overview.

• Chlorhexidine is an EML antiseptic, and its concentration matters Section 15.1 of the 24th WHO Model List (2025) carries chlorhexidine solution 5% (digluconate) among antiseptics, alongside ethanol 70% and povidone iodine. For newborn cord care, section 22.7 lists a different specification entirely: chlorhexidine 7.1% digluconate delivering 4% chlorhexidine. These are not interchangeable products. WHO Model List of Essential Medicines, 24th List (2025) — report of the 25th WHO Expert Committee (TRS 1064)
• WHO has issued a global alert on chlorhexidine misadministration WHO has recorded more than 40 cases since 2015 of serious eye injury, including blindness, where chlorhexidine gluconate 7.1% was mistaken for an eye drop or ointment. Its recommendations include selecting container designs that distinguish the product from other medicines typically used for newborns, updating the label with safe-use information, and developing clear instructions for users. WHO — Chlorhexidine 7.1% digluconate: reports of serious eye injury (Information Notice, Aug 2020)
• MSF's handling rules for cord-care chlorhexidine MSF specifies the 7.1% gel for the umbilical cord only, states it must not be used on other parts of the body, warns against combining it with soap or other antiseptics such as povidone-iodine because of incompatibility, and notes the 3 g single-dose presentation is preferred over the 20 g tube to reduce contamination from opened tubes. MSF Essential Drugs — Chlorhexidine 7.1% dermal gel

Each point above is reproduced because it has a practical consequence for 2% Chlorhexidine Gluconate Solution: the strength you can register, the pack you can release, or the wording permitted on the label. Your national prescribing information always takes precedence.

How 2% Chlorhexidine Gluconate Solution Is Tested and Released

Products are manufactured and tested against USP, EP, BP and CP monographs, with incoming raw-material inspection, in-process monitoring and full finished-product testing.

Release testing for 2% Chlorhexidine Gluconate Solution follows the monograph you nominate — USP, EP, BP or CP. If the presentation is not covered by a monograph, the specification is frozen in writing with your quality team before the batch is manufactured.

Standardised GMP production workshops with an independent R&D laboratory and a complete quality-inspection centre.

Release testing on this presentation is built around:

• Testing for description and identification
• Testing for assay of the active substance
• Testing for related substances and impurities
• Testing for dissolution or release profile (solid oral forms)
• Testing for uniformity of dosage units
• Testing for water content and pH where applicable

COA, HPLC and GC data, DMF and dossier packages, plus registration support documents for national marketing-authorisation filings.

How 2% Chlorhexidine Gluconate Solution Is Packed, Labelled and Shipped

• Shelf life: 36 months (unopened). Stability data for the marketed pack is included in the dossier.
• Labelling: artwork can be produced in English, Arabic, French, Russian and Spanish, with your own brand and language mix, subject to the labelling rules of the destination market.
• Export: GMP certificate, COA, certificate of origin, packing list and, where required, the free-sale or marketing authorisation certificate from the country of manufacture.

Regulatory Support for 2% Chlorhexidine Gluconate Solution

The legal manufacturer named on every document for 2% Chlorhexidine Gluconate Solution is Sinophare Bio-technology Co., Ltd., DML Number Jin20160068 (medicines) and Jin20160069 (paracetamol API).. The same entity appears on the GMP certificate and on the dossier submitted to your regulator.

• Method validation, stability protocol and the shelf-life justification for the marketed pack.
• Answers to authority questions during assessment, handled by the regulatory contact who prepared the file.
• Tender and framework documentation, including pre-qualification questionnaires and sample logistics.
• Artwork and mock-up approval pack, showing the carton, label and leaflet exactly as they will be printed for your market.
• Batch manufacturing and packaging records released for inspection on request during supplier audits.

2% Chlorhexidine Gluconate Solution is presented here against antiseptics and medical consumables referenced in WHO guidance. Inclusion in an essential-medicines list does not authorise sale in any particular country — the marketing authorisation for that market is a separate step.