Chlorhexidine Gluconate — field notes from a marketer who’s spent too long in cleanrooms

If you work in infection control or oral-care manufacturing, you already know the story. Still, every year there’s a new angle—better specs, tighter microbiological limits, friendlier documentation. And, to be honest, a little procurement drama. Below is the no-spin version of how Chlorhexidine Gluconate (CHG) is made, tested, and chosen, plus what buyers tell me when the cameras are off.

What it is (and isn’t)

CHG is a bisbiguanide antiseptic, typically supplied as an aqueous solution of the gluconate salt. CAS 18472-51-0, formal name 1,6-bis(N5-[p-chlorophenyl]-N1-biguanido)hexane gluconate. Market aliases include Maskin, Unisept, Chlorhexamed, sometimes “Septéal” variants. Used in pre-op skin prep, catheter care, handwash, and mouthwashes—though exact claims must follow local regs.

Quick spec snapshot

Assay (as CHG)	≈ 19.0–20.5% w/v (typical pharma grade); other strengths on request
Appearance	Clear to slightly opalescent, colorless to pale yellow solution
pH (20% sol.)	≈ 5.5–7.0
Impurities	Meets USP/Ph. Eur. related substances limits (real-world may vary by lot)
Microbial limits	TAMC/TYMC per pharmacopeia; preservative efficacy optional
Shelf life	24–36 months sealed; diluted use-solution stability depends on matrix
Origin	Tangyang Road, Xinhe County, Xingtai City, Hebei Province

How it’s made (practical view)

Materials: chlorhexidine base, gluconic acid, purified water. Methods: controlled neutralization to form Chlorhexidine Gluconate salt, coarse filtration, carbon polish (if specified), 0.22 μm sterile filtration, aseptic filling. QA/QC: identity by IR/UV, assay by HPLC, pH, color, related substances, bioburden, and time-kill verification against EN 1276/13727 or ASTM E2315 (optional). Batches for medical OEMs often add endotoxin testing and particulate counts.

Efficacy notes (the numbers buyers ask for)

– 4–5 log10 reduction of S. aureus and E. coli in 30–60 s at 0.5–2% w/v, clean conditions (ASTM E2315) — indicative, matrix dependent.
– Active in presence of light soil; heavy organic load needs formulation support (surfactants, alcohols).
– Residual activity on skin is a well-known advantage versus alcohol-only rubs.

Applications and industries

Healthcare hand antiseptics, pre-op prep, catheter-site care; dental mouthwash and gel; veterinary topicals; cosmetic preservatives (regulated); cleanroom hygiene. Many customers say they prefer CHG for “stickiness”—that lingering antimicrobial effect.

Vendor comparison (shortlist)

Vendor	Grade/Docs	Assay	Certs	Notes
Hebei Guangxin Chemical	Pharma/industrial; CoA, MSDS	≈ 20% w/v	ISO 9001; lot traceability	Stable lead times; origin Hebei, China
Global Supplier A	USP/Ph. Eur. aligned	≈ 20% w/v	ISO 13485 support (docs)	Higher MOQ; strong regulatory pack

Customization

Common requests: alternate strengths (2–20%), low-aldehyde specs for oral care, bioburden max ≤10 CFU/mL, tinted variants for process ID, and small-volume sterile fills. Packaging ranges from 1 L HDPE to 200 L drums and IBCs.

Case notes from the field

A mid-size hospital in Southeast Asia switched to a 2% Chlorhexidine Gluconate in 70% IPA scrub. Post-implementation audits showed ≈40% fewer line-associated infections over six months (confounders exist, yes), with nurses citing “less skin irritation than expected.” In dental OEMs, a 0.12% mouthwash line reported steadier taste profile after vendor moved to tighter pH control (6.0 ±0.2).

Testing standards and compliance

– Pharmacopoeias: USP/Ph. Eur./BP monographs for Chlorhexidine Gluconate Solution.
– Micro efficacy: EN 1276, EN 13727 (bactericidal); EN 13624 (yeast); ASTM E2315 time-kill.
– QMS: ISO 9001; medical customers often request ISO 13485-aligned documentation.
– Safety: follow local biocide/OTC frameworks; label claims must match jurisdiction.

Note: This article is informational; always verify suitability and regulatory status for your finished product.

References

1. CDC Infection Control Guidelines
2. WHO Guidelines on Hand Hygiene in Health Care
3. USP–NF Monograph: Chlorhexidine Gluconate Solution
4. EN 1276 / EN 13727 bactericidal standards (via national bodies)
5. ASTM E2315 Time-Kill Test Method