Hydrolyzed Collagen
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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.
Notes- For the purpose of this monograph, hydrolyzed collagen has no jelling power and is soluble in cold water (Schrieber and Gareis 2007; Moskowitz 2000).The average molecular weight of hydrolyzed collagen is approximately 4 kDa (i.e. 2-6 kDa) (Moskowitz 2000; Oesser et al. 1999).
- Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
- The solidus (/) indicates that the terms and/or statements are synonymous. Either term or statement may be selected by the applicant.
Date
December 30, 2022Proper name(s), Common name(s), Source information
Proper name(s) | Common name(s) | Source information | |
---|---|---|---|
Source material(s) | Part(s) | ||
Hydrolyzed collagen |
|
Bovine | Bovine skin/hide split |
Porcine |
| ||
Fish |
|
||
Chicken | Cartilage |
References: Proper name: ChemID 2012, ICIDH 2008; Common names: ChemID 2012, ICIDH 2008, Moskowitz 2000; Source information: Schauss et al 2012, FCC7 2010, Schrieber and Gareis 2007, Baziwane and He 2003.
Route of administration
Oral
Dosage form(s)
This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.
Acceptable dosage forms for oral use are indicated in the dosage form drop-down list of the web-based Product Licence Application form for Compendial applications.
Use(s) or Purpose(s)
- Source of (the) essential amino acid(s) (histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, valine) for the maintenance of good health and involved in protein synthesis (CNF 2010; Eastoe 1955).
- Source of (the) non-essential amino acid(s) (alanine, arginine, aspartic acid, glutamic acid, glycine, proline, serine, tyrosine) involved in protein synthesis (CNF 2010; Eastoe 1955).
- Source of the essential amino acid lysine to help in collagen formation (derMarderosian and Beutler 2011; Baziwane and He 2003; Garrison and Somer 1995; Jansen 1962)
- Helps to reduce joint pain associated with osteoarthritis (Bruyère et al. 2012; Benito-Ruiz et al. 2009; Clark et al. 2008).
Dose(s)
Subpopulation(s)
Adults 18 years and older
Quantity(ies)
Source of (the) essential amino acid(s)(histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, valine)
2.6-10 grams hydrolyzed collagen, per day (IOM 2005; Moskowitz 2000).
OR
Essential amino acids | Minimum dose (mg/day) 5% of the RDA 1 |
Maximum dose of hydrolyzed collagen (g/day)2 |
---|---|---|
L-Histidine | 49 mg | 10 g |
L-Isoleucine | 66.5 mg | |
L-Leucine | 147 mg | |
L-Lysine | 133 mg | |
L-Methionine | 66.5 mg | |
L-Phenylalanine | 115.5 mg | |
L-Threonine | 70 mg | |
L-Valine | 84 mg |
1Minimum doses have been calculated as 5% of each specific amino acid Recommended Dietary Allowance with a reference weight of 70 kg (IOM 2005).
2Maximum dose (Benito-Ruiz et al. 2009; IOM 2005; Moskowitz 2000).
Source of (the) non-essential amino acid(s) (alanine, arginine, aspartic acid, glutamic acid, glycine, proline, serine, tyrosine)
2.6-10 grams hydrolyzed collagen, per day (IOM 2005; Moskowitz 2000).
OR
Non-Essential amino acids | Minimum dose (mg/day) 5% of the RDA1 |
Maximum dose of hydrolyzed collagen (g/day)2 |
---|---|---|
L-Alanine | 181.5 mg | 10 g |
L-Arginine | 208.5 mg | |
L-Aspartic acid | 325 mg | |
L-Glutamic acid | 750 mg | |
Glycine | 160 mg | |
L-Proline | 259.5 mg | |
L-Serine | 175.5 mg | |
L-Tyrosine | 139 mg |
1Minimum doses have been calculated as 5% of each specific amino acid Mean Intake (IOM 2005)
2Maximum dose (Benito-Ruiz et al. 2009; IOM 2005; Moskowitz 2000).
Source of lysine
Essential amino acids | Minimum dose(mg/day) 5% of the RDA1 |
Maximum dose of hydrolyzed collagen (g/day)2 |
---|---|---|
L-Lysine | 133 mg | 10 g |
1Minimum doses have been calculated as 5% of Recommended Dietary Allowance with a reference weight of 70 kg (IOM 2005).
2Maximum dose (Benito-Ruiz et al. 2009; IOM 2005; Moskowitz 2000).