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Test Method - Glutathione Powder

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Update time : 2022-08-30 18:48:21



1 Scope

This standard specifies the classification, requirements, test methods, inspection rules and labeling, packaging, transportation and storage of glutathione products.

This standard applies to the glutathione products produced and sold by our company.

2 Normative references

The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the most
The new edition (including all amendments) applies to this document.
GB/T 191 Graphical signs of packaging, storage and transportation
GB/T 5917.1 Determination of Feed Pulverization Particle Size Two-layer Sieve Screening Method
GB/T 6435 Determination of moisture and other volatile substances in feed
GB/T 14699.1 Feed sampling method
GB/T 18823 Judgment Error of Feed Test Results
GB/T 18869 Determination of Coliforms in Feed
GB 10648 Feed Label
GB 13078 Feed Hygiene Standard
Order No. 75 of the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China Measures for the Supervision and Administration of the Measurement of Quantitative Packaged Commodities
JJF1070-2005 Rules for measurement and inspection of net content of quantitatively packaged commodities

3 product categories

Product name Trade name Product type Addition amount (per ton of compound feed)
Glutathione Glutathione Yeast General Purpose for Livestock, Poultry and Aquatic Products 10~100g

4 Requirements

4.1 Raw materials
4.1.1 Feed additives
The product should obtain the production license and approval number or trial production approval number, and glutathione should meet the corresponding product standards.
4.1.2 Overseas feed and medicated feed additives
An import registration certificate should be obtained.
4.1.3 Carriers and diluents
It should comply with the corresponding national standards, industry standards and the provisions of GB 13078, and should not use contraband.
4.2 Sensory indicators
Consistent color, no fermentation mildew, caking and odor, smell.
4.3 Moisture
Moisture not higher than 10.0%.
4.4 Processing quality standards
Specification: 98% Packing: 10kg/drum Min. Purchase Quantity: 1
CAS: 70-18-8 Molecular formula: C10H17N3O6S Molecular weight: 307.32
Quality Inspection
Quality standard Q/STY 012-2017
4.4.1 Finished particle size
98% pass through the 2.80mm standard sieve, and the 1.40mm standard sieve is less than or equal to 20%.
4.4.2 Mixing uniformity
The coefficient of variation of mixing uniformity should not be greater than 7%.
4.5 The technical indicators of glutathione products are shown in Table 2.
Table 2 Guaranteed value of glutathione product composition analysis
Item Glutathione
Glutathionease activity, 10,000 U/g ≥ 500.0
4.6 Hygiene Standards
Should comply with the provisions of GB 13078 and Table 2.
4.7 Net Content
It shall comply with the provisions of Order No. 75 of the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China.

5 Test methods

5.1 Sensory indicators
sight, feel, nose.
5.2 Mixing uniformity
At least 10 samples were taken from each batch of products to determine the glutathione content in each sample, and the mean and coefficient of variation were calculated.
Q/STY 012-2017
5.7 Net content
Execute in accordance with the provisions of JJF1070.
5.8 Determination of glutathione content
This product contains glutathione (enzyme activity per 1g not less than 5,000,000 units) should be more than 85.0% of the labeled amount.
traits
This product is a white or slightly yellow crystalline or amorphous powder, odorless and sweet, and the aqueous solution is easily destroyed by alkali.
This product is easily soluble in water, but insoluble in acetone and ether.
an examination
(1) PH value: The 1% aqueous solution of this product should have a PH value of 3.0 to 6.5. ("Chinese Veterinary Pharmacopoeia" 1990 edition one
Appendix 29)
(2) Residue on ignition: not more than 10%. ("Chinese Veterinary Pharmacopoeia" 1990 edition, appendix 39 pages)
(3) Loss on drying: take 0.5g of this product, dry it under reduced pressure at 80°C for 3 hours, and the weight loss should not exceed 8.0%.
(4) Others should comply with the relevant regulations under the powder.
Enzyme activity assay
(1) Determination of enzyme activity
Accurately measure 4ml of the substrate suspension, put it into a cuvette, use spectrophotometry, according to the appendix of the 1977 edition of the Chinese Pharmacopoeia, measure the absorbance at a wavelength of 450nm, as the zero hour
Read, then measure sample solution (equivalent to 8 μg glutathione), add to cuvette, mix quickly, count time with stopwatch, measure absorbance every 30 seconds to 90 seconds
A total of four absorbance readings were recorded, according to the definition of unit activity at 25°C, PH6.2, and wavelength 450nm, the absorbance decreased by 0.001 per minute as one unit of enzyme activity.
Calculate by the following formula.
Calculation formula: (absorbance at zero time-absorptivity at 60 seconds)×(1000/sample μg)×1000=units of enzyme per 1mg

6 Inspection standard

6.1 Definition Description
L-r glutamyl-L-cysteinyl glycine
Content: Calculated by dry product, 98.0%-101.0%
6.1.1 Characters
Appearance properties: white or almost white crystalline powder or colorless crystal.
Solubility: easily soluble in water, slightly soluble in 96% ethanol and dichloromethane.
6.1.2 Authentication
A Specific rotation conforms to a specific optical rotation assay (see Determinations).
B Infrared absorption spectrum detection (2.2.24)
Contrast: Glutathione CRS.
6.1.3 Determination
Solution S: Take 5.0g of this product, dissolve it in distilled water R and dilute to 50ml.
Solution Clarity Solution S is clear (2.2.1), colorless (2.2.2, Method II)
Specific rotation (2.2.7) -15.5~-17.5 (dry substance)
Take 1.0g of this product, dissolve it in distilled water R and dilute to 25.0ml.
Relevant substances using capillary electrophoresis (2.2.47)
6.1.4 The solution should be freshly prepared before use
capillary
-Material: Quartz (uncoated)
- Dimensions: effective length 0.5m, overall length: 0.6m, inner diameter 75 μm
Temperature: 25℃
Electrolyte solution: take anhydrous sodium dihydrogen phosphate R1.50g, add water R230.0ml, adjust the pH value to 1.80 with phosphoric acid R.
Add water R to dilute to 150.0ml, check the pH value, and adjust the pH value with phosphoric acid R or sodium hydroxide solution R if necessary.
Detection: Spectrophotometer at 200 nm
Pretreatment of the new capillary: before the first injection, rinse the capillary with 0.1mol/L hydrochloric acid solution under the pressure of 138Kpa for 20min, and rinse it with water R under the pressure of 138Kpa for 10 minutes.
To reach full equilibrium, rinse with electrolyte solution at 350kpa for 40min, and keep at voltage 20kv for 60min.
Pretreated capillary: under 138 kPa pressure, rinse the capillary with electrolyte solution for 40min;
Rinse between batches: under the pressure of 138 kPa, rinse the capillary with water R for 1 min, 0.1mol/L sodium hydroxide solution for 2 min; rinse with water R for 1 min, rinse with 0.1mol/L hydrochloric acid solution
Wash for 3min, and finally rinse with electrolyte solution for 10min;
Injection: 3.45 kPa pressure for 5s; inject electrolyte solution (blank solution), control solutions (b), (c) and test solutions a, b
Migration: Voltage is 20KV
Running time: 45min
Relative mobility: relative to the internal standard substance (about 14min)
Impurity A=about 0.77
Impurity B=about 1.04; Impurity E=about 1.2
Impurity C=about 1.26; Impurity D=about 1.3
6.1.6 System suitability
Resolution: A min. of 1.5 between the peak produced by the internal standard and the peak produced by the impurity B in control solution C, e.g.
If necessary, adjust the pH with dilute sodium hydroxide solution
Peak-to-valley ratio: lowest position 2.5. Where: HP=height above the baseline peak due to impurity D HV=height above the lowest point of the separation curve of the peak produced by glutathione in the control solution
The pH was adjusted down with phosphoric acid if necessary.
When the above items are determined by electrophoresis, the test solution a has no peak at the same migration time as the internal standard substance (can be corrected by the phenylalanine peak)
Limit test solution B
Corrected area: relative migration time divided by the sum of all peak areas
Correction factor:
Impurities A, B, E:
Chloride should not exceed 200ppm
Take 2.5ml of solution S, add water R to dilute to 15ml.
Sulfate shall not exceed 300ppm
Take 2.5ml of solution S, add distilled water R to dilute to 15ml
Ammonium salts must not exceed 200ppm
Iron must not exceed 10ppm

7 Labeling, packaging, transportation, storage

7.1 Labels
Execute in accordance with GB 10648.
7.2 Packaging
7.2.1 Packaging Requirements
Should comply with the provisions of Article 14 in GB 191.
7.2.2 Packaging Specifications
According to the needs of users and the production and sales of enterprises, product packaging can be divided into different specifications.
7.2.3 Packaging materials
Products should be packaged in non-toxic plastic bottles or non-toxic aluminum foil composite bags; they should be sealed, waterproof, protected from light, and have certain strength requirements.
7.3 Transport
When the product is transported, the means of transport shall be clean, clean, non-polluting and non-toxic, and shall be protected from exposure to sunlight, rain and damage during transportation.
7.4 Storage
Products should be stored in a dry, cool and ventilated warehouse to prevent moisture and damage, and should not be stored with toxic and pollutants.
7.5 Shelf life
The shelf life of the product is 24 months from the date of manufacture under the transport and storage conditions specified in this standard.



 
 


 
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