Indole-3-carbinol Powder

Indole 3 Carbinol Powder Supplier:

Guanjie Biotech is a professional bulk Indole-3-carbinol Powder manufacturer. We have raw material synthesis workshop and adheres strict I3C powder quality standard. The appearance of this product is off white to white crystalline powder. Guanjie Biotech has been on this line for more than 20 years, there are more than 15 engineers in our team. We have got more than 14 patents. This ensures that the products we provide are of excellent quality and stable performance. And we have a sales team of 30 people in China to serve our customers, as well as offices and warehouses in the United States and the United Kingdom. It would be a wise choice for you to be our customer.

 

Indole-3-carbinol powder is produced by the breakdown of the glucosinolate glucobrassicin,which is obtained from the decomposition of brassica glucoside thioside. It can be found at relatively high levels in cruciferous vegetables such as broccoli, cabbage, cauliflower, brussels sprouts, collard greens and kale. It is also available in dietary supplements. It stores in cool & dry place, Keep away from strong light and heat under 0-8°C.

 

Product quality steps:

◆ We will prepare Indole-3-carbinol Powder samples for approval;

◆ After getting approved, our team will set up a process craft, and form a inside drawing to follow it;

◆ During production, we have FQC, IQC, IPQC and OQC to control the quality.

 

COA

Product Name: pure indole 3 carbinol
Items	Standard	Results	Test Method
Appearance	Off white to white crystalline powder	Conform	Visual
Odor, Taste	Characteristic	Conform	Sensory
Mesh size	98%pass 80mesh	Conform	GB/T 5507-2008
Content	≥99.0%	99.1%	HPLC
Residue Ignition	≤0.1%	0.06%	GB/T 9741-2008
Loss on drying	≤1.0%	0.6%	GB 5009.3-2016
Melting Point	92 -99℃	96.5℃	GB/T 21781-2008
Heavy Metals	≤10 ppm	Conform	GB 5009.74-2014
Pb	≤2 ppm	Conform	GB 5009.12-2017
As	≤2 ppm	Conform	GB/T 5009.11-2014
Hg	≤0.5ppm	Conform	GB/T 5009.17-2014
Cd	≤0.5ppm	Conform	GB 5009.15-2014
Solvent Residue	No toluene or benzene	Absent	GB 5009.262-2016
Total plate count	≤1000 cfu/g	Conform	GB 4789.2－2016
Mold&Yeast	≤ 100cfu/g	Conform	GB 4789.15－2016
E.coli	Absent	Absent	GB 4789.38-2012
Salmonella	Absent	Absent	GB 4789.31-2016
Staphylococcus aureus	Absent	Absent	GB 4789.10-2016

Flow Chart:

 

Indole-3-carbinol Test Sop

(Standard Operating Procedure)

1. Objective: Establish standard operating procedure of Indole-3-carbinol Powder, ensure the accuracy of test results.

2.Scope:Indole-3-carbinol finished products

3.Responsibility: QC

4.Test standard: Customer standard

 

5. Procedures:

5.1 [Properties] This product is white or almost white crystalline powder.

5.2. [Solubility] hardly soluble in water, soluble in ethanol (96%), slightly soluble in dichloromethane.

5.3 Check

5.4.1 Loss on drying: Not more than 1.0%

5.4.1.1. Instruments and reagents: electronic balance (d = 0.01mg), electric oven thermostat.

5.4.1.2. Steps:

Weigh about 100mg sample, weigh in a flat weighing flask with constant weight, drying at 45 ℃ for two hours, remove to transfer to desiccator at room temperature, accurately weighed, record data, remove to continue 45 ° C oven dried for two hours. Transfer dryer to room temperature, accurately weighed record data. Two data error should be less than 0.3mg.

5.5 Content standard requirements: 98% -102% (on dry basis)

Instrument and reagent

Electronic balance (d = 0.01mg), HPLC(high performance liquid chromatography), methanol (HPLC grade),

purified water, triethylamine (AR).

 

6. Chromatographic conditions

The column: Xtimate C18, 4.6X250mm 5μm.

Mobile phase: methanol: water (60:40), triethylamine adjusted to pH = 8.0,degassing.

Wavelength: 254nm Column temperature: 30 ℃

Flow rate: 1.0ml/min Injection volume: 20μl.

 

The measurement procedure: Contrast d:Dissolve 10mg Indole-3-carbinol Powder standard product into 25ml volumetric flask,into the contrast d6 times RSD%<2.0%, accurately weighed two samples to be tested 10mg, respectively, to 25 ml brown volumetric flask, dissolved in methanol, ultrasound 5min at room temperature for injection.

 

7. Data recording and calculation: external standard method

As --Sample peak area

WS --Sample weighed

AR --Standard peak area

WR --Standard product weighed

A--Sample loss on drying

CR --Standard content

 

8. Operation Cautions:

1.This Indole-3-carbinol Powder product is sensitive to light and heat, with the influence of temperature and time. Experiment must be as fast as possible, and should be avoid light and air.

2.The goods stored in a sealed container, protected from light, keep under -10 ° C or less.

HPLC digital fingerprint

 

Stability Test Methods

● Introduction:

The purpose of stability testing is to provide evidence on how the quality of Indole-3-carbinol Powder varies with time under the influences of temperature and humidity and to

establish recommended storage conditions, retest periods and shelf life.

● Responsibility:

QA/QC Director is responsible for the stability study program and is also responsible for the stability samples analyzed as well as the maintenance of the program records.

● Procedure and Design of Stability Studies:

● Long Term Studies:

The samples of Indole-3-Carbinol are closed tightly in polyethylene bags, sealed in PE bags and packaged in aluminum containers. They are stored under long-term conditions of 252℃ temperature and 60±5% humidity conditions according to ICH/FDA guidelines. The three consecutive process validation batches and one batch every year are sampled and placed on long term stability testing. After the initial analysis, these samples will be analyzed at intervals of 3, 6, 9, 12 and 15 months. The results to date demonstrate that Indole-3-Carbinol is stable at 25±2℃temperature and 60±5% humidity conditions.

 

Accelerated Studies:

The samples of pure Indole-3-Carbinol are placed in polyethylene bags, sealed in PE bags, packaged in aluminum containers and stored at 40±2℃ and 75±5% humidity conditions. The three consecutive batches are taken for testing. After the initial analysis, these samples are analyzed at 1, 2, 3 and 6 months according to ICH Guidelines. The results to date demonstrate that Indole-3-carbinol Powder is stable at 40±2℃ temperature and 75±5% humidity conditions.

 

Accelerated Studies:

The samples of Indole-3-carbinol Powder are placed in polyethylene bags, sealed in PE bags, packaged in aluminum containers and stored at 40±2℃ and 75±5% humidity conditions. The three consecutive batches are taken for testing. After the initial analysis, these samples are analyzed at 1, 2, 3 and 6 months according to ICH Guidelines. The results to date demonstrate that Indole-3-Carbinol is stable at 40±2℃ temperature and 75±5% humidity conditions.

 

Degradation Study:
The purpose of the degradation study is to determine if the HPLC method used by our facility for product release and stability studies will detect impurities and as a result is stability indicating. Three lots on stability, IC140910, IC140926, IC140930 were chosen and samples from these lots were subjected to:
a. Sodium Hydroxide, 0.00001 N
b. Hydrochloric Acid, 0.04 N
c. Hydrogen Peroxide, 10%
d. Heat at 60℃
e. Ultraviolet light

Application

◆ Medicine Field:

◆ Health Care Field:

As an antioxidant and anti-aging agent, it can scavenge free radicals, promote cell metabolism, prevent aging and skincare maintenance. And it can also reduce senile heart disease, hyperglycemia, and Alzheimer's disease, and prolong life.

◆ Cosmetics Field:

Indole-3-carbinol Powder can be added to cosmetics, skincare, and anti-aging.

 

Function

◆ Regulation of estrogen

Indole-3-methanol inhibits estrogen synthesis, blocks estrogen-related pathways, and inhibits estrogen-induced cell proliferation.Because of the existence of these mechanisms, indole-3-methanol is thought to be used to regulate diseases associated with hyperestrogenism.

◆ Indole-3-carbinol powder is used for the treatment of fibromyalgia, virus-induced intralarynx tumor (laryngeal papillomatosis), virus-induced respiratory tract tumor (respiratory papillomatosis), abnormal growth of cervical cells (cervical dysplasia), systemic erythema Lupus (SLE).

 

Product Qualification

Indole-3-carbinol Bulk Powder is produced in a clean working environment and every step of the process is conducted by highly qualified professionals. Both the production processes of manufacture and the product itself meet all international standards. And if you need our testing report, we can provide you.

 

Our factory:

There are two factories both in Baoji city and Shangluo City, Guanjie factories covers an area of 7000㎡, including GMP standard workshop of 2000㎡.

 

Certification

We have obtained the NON-GMO by Pony test international group. And we get the certifications about HALAAL,ISO 9001,ISO 22000,Kosher, PAHS,SC and so on.

 

Package&Warehouse:

 

Shipment:

DHL, Sea freight, FEDEX, you can choose.

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