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. 2021 Nov 12;7(4):207. doi: 10.3390/gels7040207

Table 6.

Regulatory information about some hydrogel ingredients [158].

Common Name USP-NF Name Preferred Substance Name (USFDA) EP Name CAS No. Maximum Potency per Unit Topical Dose(as per USFDA) Relevant Physico-Chemical Properties GRAS Listed
Alginate Alginic acid, sodium alginate Sodium alginate Alginate, sodium 9005-38-3 0.25% w/w Dissolves in water and forms a viscous solution
Collagen Gelatin Type II Collagen Collagen 9007-34-5 8% w/w
Gelatin Gelatin Gelatin Gelatin 9000-70-8 350 mg
PEG 200 Polyethylene glycol 200 Polyethylene glycol 200 Polyethylene glycol 200 112,607 39% w/w Viscosity 3.9–4.8 mPas at 98 °C
PEG 1000 Polyethylene glycol 1000 Polyethylene glycol 1000 Polyethylene glycol 1000 25,322,683 0.5% w/w Viscosity 16–19 mPas at 98 °C
PEG 1600 Polyethylene glycol 1600 Polyethylene glycol 1600 Polyethylene glycol 1600 25,322,683 29.7% w/w Viscosity 28–36 mPas at 98 °C
PEG 300 Polyethylene glycol 300 Polyethylene glycol 300 Polyethylene glycol 300 25,322,683 57% w/w Viscosity 5.4–6.4 mPas at 98 °C
PEG 400 Polyethylene glycol 400 Polyethylene glycol 400 Polyethylene glycol 400 25,322,683 99% w/v Viscosity 6.8–8 mPas at 98 °C
Polyacrylic acid Poly(acrylic acid) Polyacrylic acid Polyacrylate 9003-01-4 196 mg Viscosity 50–200 mPas at 20 °C
Polyvinyl alcohol Polyvinyl alcohol Polyvinyl alcohol Polyvinyl alcohol 9002-89-5 140 mg
Polyacrylamide Polyacrylamide Polyacrylamide Polyacrylamide 9003-05-8 5% w/w

USP NF—United States Pharmacopeia (USP) and the National Formulary (NF); USFDA—United States Food and Drug Administration; GRAS—Generally recognized as safe.