Cytisine 98% HPLC
Product Name: cytisine
Quality standard: National Standard
CAS NO: 485-35-8
Appearance: White powder
Storage method: The product should be sealed and stored in a cool and dry place.
Shelf life: 24 months
Source of extraction: Sophona alopecuroides L seed
Package specification: 1kg / aluminum foil bag, 25kg/Drum or as required by customers
Product introduction:Cytisine (also known as baptitoxine and sophorine) is a kind of naturally occurring alkaloid that can be found in several plant genera including Laburnum and Cytisus in the family Fabaceae
This technical requirement specifies the technical requirements, test method, test rules and label of Cytisine.
The requirements of this standard apply to the raw material of Cytisine made by the processing of extracts.
- Standardization of reference documentThe terms in the following documents become terms of this technical requirement by reference to them. All subsequent amendments (excluding errata) or revisions to dated references shall not apply to this Technical Requirement; however, the parties to an agreement under this Technical Requirement are encouraged to study the availability of the latest version of these documents. For undated references, the latest version is applicable to this technical requirement.GB/T 5009.11 Determination of total arsenic and inorganic arsenic in food componentGB/T 5009.12 Determination of lead in foodsGB/T 5009.15 Determination of cadmium in foods
GB/T 5009.17 Determination of total and organic mercury in foodstuffs
GB/T 5009.19 Determination of multi – residues of organochlorine pesticides in food
GB 4789.2 Microbiological testing of food hygiene – determination of total number of colonies
GB 4789.3 Microbiological testing of food hygiene – determination of coliform bacteria
GB 4789.15 Food hygiene microbiology test for mold and yeast counts
Pharmacopoeia of the People’s Republic of China (2015 edition)
- Structural formula
cytisine Molecular formula C11H14NO Molecular weight 190.24
- Technical requirements
- Technical requirement
- Raw material
- Plant raw materials are harvested in winter to remove impurities and dry.
4.2 Sensory requirement
Conform to the requirement of chart 1
Chart 1 Sensory index
cytisine smell, bitter in taste.
4.3 Symbolic ingredient
Conform to chart 2 requirement
Chart 2 Symbolic ingredient
According to dry powder cytisine purity（g/100g）
More than 98.0
4.4 Physicochemical requirement
Conform to chart 3 requirement
Chart 3 Physicochemical requirement
|Partical size[80 mesh pass （%）] ≧||
|Ash content（%） ≦||
|Hexachloro-cyclohexane soprocide （mg/kg） ≦||
|DDT （mg/kg） ≦||
|Huintozene （mg/kg） ≦||
4.5 Microbiological indicator
Conform to chart 4 requirement
Chart 4 Microbiological indicators
|Total Plate Count/（cfu/g） ≦||
|Yeast & Mold/（cfu/g） ≦||
5 Test method
5.1 After opening the sample, smell its smell and taste its taste immediately ;In addition, appropriate amount of the sample was placed in a white porcelain plate to observe its color and appearance, and to check for foreign bodies.
5.2 Physicochemical requirement
5.2.1 The purity of Cytisine The method was determined according to Appendix A
The test was carried out according to the screening method stipulated in the General Rule 0982(Second Method) of the Fourth Part of the Pharmacopoeia of the People’s Republic of China (2015).
The assay was conducted according to the method specified in General Rule 0832(second method) of the fourth part of Pharmacopoeia of the People’s Republic of China (2015 edition).
5.2.4 Ash content
The assay was carried out according to the method specified in General Rule 1106 of the fourth part of Pharmacopoeia of the People’s Republic of China (2015 edition)
The total arsenic and inorganic arsenic in food were determined according to GB/T 5009.11 method.
According to GB/T 5009.12 for the determination of lead in food.
Cadmium in food was determined according to GB/T 5009.15.
The total mercury and inorganic mercury in food were determined according to GB/T 5009.17.
5.2.9 Hexachloro-cyclohexane soprocide DDT Huintozene
Execute according to GB/T 5009.19
5.4 Bacteriological examination
5.4.1 Total Plate Count
In accordance with the “national food hygiene standard” GB4789.2
5.4.2 Yeast & Mold
In accordance with the “national food hygiene standard” GB4789.15
In accordance with the “national food hygiene standard” GB4789.3
In accordance with the “national food hygiene standard” GB4789.4
In accordance with the “national food hygiene standard” GB4789.10
6 Test rule
Samples were taken according to the method specified in the General Rule 0211 of the Four Parts of the Pharmacopoeia of the People’s Republic of China (2015 edition), and the products that were evenly mixed and had the same nature and quality within a certain limit were tested as the same batch.
6.2 Inspection Classification
6.2.1 Delivery inspection
Before leaving the factory, the quality inspection department of the factory shall inspect the products batch by batch according to the requirements of 4.2 ~ 4.5, and the products that pass the inspection and issue the quality certificate can be sold before leaving the factory.
6.2.2 Test type
Carry out type inspection according to chapter 4.Type inspection shall be carried out every six months in case of any of the following situations:
A) when there is a big change in raw materials;
B) Adjustment of key processes;
C) Resuming production after replacing equipment or stopping production;
D) There is a big difference between the results of ex-factory inspection and the last type inspection.
6.3 Decision rules
6.3.1 If one of the inspection results does not meet the technical requirements, samples of twice the quantity shall be randomly selected from the same batch of products for re-inspection, and the re-inspection result shall prevail. If there is still one index unqualified in the reinspection, the batch of products will be judged as unqualified.
6.3.2 If any item in the microbial project does not meet the technical requirements, it will be judged as unqualified and will not be re-inspected.
6.3.3 Determination of type inspection is the same as that of factory inspection.
Labeling, packaging, transportation and storage
7.1 The label
7.1.1 The packaging label shall mark: sample name, date of production, batch number of production, specification, gross weight, net weight and execution standard.
7.1.2 The label content is clearly visible and the label is firmly pasted.
7.2 The packing
Packaging materials should meet the requirements of food hygiene.The packaging materials shall be inspected strictly before use.After the barrel is packed, it should be sealed with a seal label.
7.3.1 The means of transport shall be clean and hygienic, and shall not be mixed with poisonous, harmful, corrosive or odor articles.
7.3.2 Light load and light discharge shall be carried out, and extrusion, exposure and rain shall be prevented during transportation.
7.4.1 The product shall not be stored mixed with toxic, harmful, corrosive or peculiar smell.
7.4.2 The product should be sealed and stored in a cool and dry place.
7.5 Shelf life
Shelf life is 24 months.
Test method for Cytisine
Properties:This product is white powder;NLT 100%
Pass 80 mesh;odorless,characteristic smell
Loss on drying: measured according to the General Principles of Chinese Pharmacopoeia 2015 Edition 0831 method, which requires loss on drying ≤1%
Heavy metals: According to the 0821 method of “Chinese Pharmacopoeia” 2015 General Rules, the total amount of heavy metals ≤10PPM, arsenic ≤2PPM, lead ≤2PPM
Ash content: Refer to the “Chinese Pharmacopoeia” 2015 version of the general rule 2302 method for determination, ash content ≤0.1%
Microbiological indicators: refer to the pharmacopoeia guidelines
Pesticide residues: batches are sent to a third-party testing agency for testing, and are implemented in accordance with relevant standards
Determination of content (HPLC): ≥98% based on our company ’s reference substance
Test wavelength: 230nm
Column: Hypersil ODS2 C18 5μ 250 * 4.6mm
Mobile phase: acetonitrile: 0.02% ammonium acetate: triethylamine = 15: 85: 0.02ml
Flow rate: 0.8 ml / min
Configuration of reference solution
Precisely weigh 10 mg of the genistein reference substance in a 25 ml volumetric flask, dissolve it in 15 ml of methanol with ultrasound. After cooling, dilute to a fixed volume and place in a 25ml volumetric flask, shake well.
Preparation of test solution:
Precise weighing: Equivalent to the amount of reference substance in the 25 ml volumetric flask. Use 15ml methanol to dissolve ultrasonically. After cooling, dilute to a fixed volume and place in a 25ml volumetric flask.
Determination: Precisionly draw 15μl each of the reference solution and the test solution, and inject it into the liquid chromatograph for measurement, and record the peak areas of the reference and test products.
Sample content Wx = A1 * C2 * Ws / A2 * C1
C1 ------- Concentration of test product
C2 ------- Control substance concentration
A1 ------- Peak area of test product
A2 ------- Peak area of reference substance
Ws ------- (our company) the content of reference substance is 98%
Wx -------- Test product content