Tetrandrine98%

Product Name: Tetrandrine

Quality standard: National Standard

Specification: 98%

Test method:HPLC

CAS NO: 518-34-3

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: Stephania tetrandra S. Moore root

Package specification: 1kg / aluminum foil bag, 25kg/Drum or as required by customers

Product introduction: Tetrandrine is a kind of dibenzylisoquinoline alkaloid. It is a dimer formed by two benzylisoquinoline subunits through two ether bonds connected head to head and tail to tail respectively. Tetrandrine is almost insoluble in water, petroleum ether, ether and some organic solvents.

Tetrandrine

1. RangeThis specification specifies the technical requirements, test methods, test rules and label of tetrandrine.The requirements of this standard are applicable to products obtained by extraction, chromatography, and recrystallization using tetrandrine as raw material

1. 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 foodGB/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 – component 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)

1. Structual formulaTetrandrine      Molecular formula C38H42N2O6   Molecular weight 622.75
2. Technical requirements

 4.1 Technical requirement

4.1.1 The raw material was dried rhizome of tetrandrine. According to the calculation of dried products, the total purity of tetrandrine (C38H42N2O6) and tetrandrine (C38H40N2O6) should not be less than 1.6%.

4.1.2 Technological process  Tetrandrine was extracted three times with 95% ethanol reflux, and the specific gravity of the extract was controlled to 1.25. Add hydrochloric acid lotion to the concentrated solution several times, filter the insoluble matter with a plate and frame, adjust the PH neutrality with alkali, filter the precipitate with a plate and frame and dry. Dissolve the precipitate and apply it to a chromatography column, collect tetrandrine A and tetrandrine B in sections, and follow up TLC detection during the process.Make sure that the content of tetrandrinee is greater than 98%. The product is crushed and dried in a vacuum oven, and the temperature is controlled at 85°C to prevent carbonization of the product. After drying, the finished products will be put into the finished product warehouse after passing the test according to the enterprise standard.

4.2  Sensory requirement

 Conform to the requirement of chart 1

Chart 1  Sensory index

4.3 Symbolic ingredient

Conform to chart 2 requirement

Chart 2   Symbolic ingredient

4.4 Physicochemical requirement

Conform to chart 3 requirement

Chart 3 Physicochemical requirement

4.5 Microbiological indicator

Conform to chart 4 requirement

Chart 4 Microbiological indicators

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 Tetrandrine  The method was determined according to Appendix A

5.2.2 Mesh

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).

5.2.3 Moisture

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)

5.2.5 Arsenic

The total arsenic and inorganic arsenic in food were determined according to GB/T 5009.11 method.

5.2.6 Lead

According to GB/T 5009.12 for the determination of lead in food.

5.2.7 Cadmium

Cadmium in food was determined according to GB/T 5009.15.

5.2.8 Hg

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

5.4.3 E.Coli

In accordance with the “national food hygiene standard” GB4789.3

5.4.4 Salmonella

In accordance with the “national food hygiene standard” GB4789.4

5.4.5 Staphylococcus

In accordance with the “national food hygiene standard” GB4789.10

6 Test rule

6.1 Test

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 Transportation

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 Storage

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.