Slide 1

Commercial Collagen Products

1. Gelatin

• an irreversibly denatured (Heat or Acid) form of collagen (usually

types I & III) used in food and cosmetics industry

2. Partially denatured

(physical breakdown)

or non-hydrolyzed :

• All types (I/III and II are most common)

• High molecular weight

• Limited water solubility (soluble in mildly acidic solutions)

3 Hydrolyzed

• Type I/III (derived from beef, pig or fish skin and bones)

• Type II (usually from chicken sternal cartilage), can be

SMPR Key Points

Applicability

The method will be able to identify

and quantify individual native (un‐

denatured) and hydrolyzed collagen

Validation Guidance

Data demonstrating that a candidate

method is able to: Separate a

type I, II & III if one or multiple types

are present in dietary ingredients

and dietary supplement finished

products.

com nat on o nat ve co agen type I,

II and III and/or hydrolyzed collagen

type I, II and III. Quantify each

individual collagen type both native

and hydrolyzed.

Parameter

Criteria

Table 1: Method performance requirements

Analytical Range (%)

1 – 100

LOQ (%)

0.5

Recovery (%)

90‐110

% RSD

≤ 5

% RSD

≤ 10