Details:

Our advantage:

1. High quality with competitive price:

1) Standard:BP/USP/EP/Enterprise standard

2) All Purity≥99%

3) We are manufacturer and can provide high quality products with factory price.

 2, Fast and safe delivery

1) Parcel can be sent out in 24 hours after payment.Tracking number available

2) Secure and discreet shipment.Various transportation methods for your choice.

3) Customs pass rate ≥99%

4) We have our own agent/remailer/distributor who can help us ship our products very fast and safe,

and we have stock in there for transferring.

This product contains pancreatic kininogenase titer should not be less than 85.0% of the label.

trait

This product is an enteric-coated tablet, white or off-white after removal of the coating.

identification

In the chromatogram recorded under the purity item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.

examination

• purity take this product 5 to remove the coating, fine, weigh the appropriate amount of fine powder, put it in the centrifuge tube, add an appropriate amount of mobile phase A to dissolve and dilute pancreatic kininogenase to make A solution containing about 200 units of pancreatic kininogenase per 1 ml, mix for 2 minutes on A vortex shaker, and centrifuge (3000 revolutions per minute) for 15 minutes, take the supernatant and filter 5 and take the filtrate as the test solution; Take 1.3g of starch, 0.36g of dextrin and 0.52g of microcrystalline cellulose, put them into the centrifuge tube, add A3ml of mobile phase, and operate with the same method, take the continued filtrate as the auxiliary solution; Take the appropriate amount of pancreatic kininogenase reference substance (purity should be greater than 95%), add mobile phase A to dissolve and dilute to prepare A solution containing about 400 units per 1 ml as the reference solution; take an equal volume of The excipient solution and the reference solution, mix, as the system applicable solution. Hydrophobic gel (TSKgel Phenyl-5PW, 0512 x 75mm, 10um or other suitable chromatographic column) as tested by high performance liquid chromatography (General 7.5mm); with 1.7mol/L ammonium sulfate phosphate buffer (pH 7.0 )(take disodium hydrogen phosphate 10.9g, sodium dihydrogen phosphate 2.3g, add water to dissolve and dilute to 1000ml, adjust the pH value to 50% with 7.0 phosphoric acid solution) the solution was mobile phase A, and the temperature of the mobile phase column was 25 ° C. With the above phosphate buffer (pH 7.0); The flow rate was 0.5ml per minute; And the detection wavelength was 280nm. The linear gradient elution was performed as follows. 20ul of the mobile phase A and the applicable solution of the system were injected into the liquid chromatograph respectively, and the chromatograms were recorded. The chromatogram of the system-applicable solution was subtracted from the chromatogram of mobile phase A (as A blank baseline) and baseline corrected. The retention time of the excipient impurity peak was about 36 minutes, and the retention time of the pancreatic kininogenase peak was about 46 minutes. The number of theoretical plates shall not be less than 1500 calculated by pancreatic kininogenase peak, and the separation degree between pancreatic kininogenase peak and impurity peak of auxiliary material shall be greater than 3.0. 20ul of the test solution and the reference solution were respectively injected into the human liquid chromatograph to record the chromatogram, and the baseline correction was carried out according to the above method and the same method. In the chromatogram of the test solution, the area of each chromatographic peak after measuring the impurity peak of the auxiliary material shall be calculated by the peak area normalization method, and the area of the main peak consistent with the retention time of the main peak of the reference solution shall not be less than 70%.
• Content uniformity: Take 10 tablets of this product, remove the coating for 5 min, add appropriate amount of phosphate buffer solution (pH 7.0) under the item of purity respectively, and grind to dissolve pancreatic kininogenase, and quantitatively dilute into a solution containing 10 units of pancreatic kininogenase per 1 ml, filter, take the filtrate as the test solution, and measure according to the method under the item of potency determination of pancreatic kininogenase, comparing the potency of each tablet with the average potency of 10 tablets, the potency greater than ± 10% of the average potency shall not exceed 1 tablet and shall not exceed ± 15%; the relative standard deviation of the titer of 10 tablets should not be more than 6.0%.
• dissolution of this product, according to the dissolution and release determination method (General 0931, using the first method and the second method of enteric preparation method 2, instrument device using the third method), with 0.lmol/L hydrochloric acid solution 100ml as the dissolution medium, the speed is 75 revolutions per minute, according to the law, after 1 hour, the tablet should not have cracks, disintegration phenomenon. Discard the acid solution in each dissolution Cup, quickly rinse with water for several times, immediately add 100ml of phosphate buffer solution (pH 6.8) at the same temperature as the acid solution, continue to operate according to law, and take about 10ml of the solution after 45 minutes, filter, take the filtrate as the test solution; Take the appropriate amount of pancreatic kininogenase standard, add the above phosphate buffer (pH 6.8) according to the marked unit dissolve and quantitatively dilute to prepare a solution containing about 0.5 units (60 unit specification) or 1 unit (120 unit specification) or 2 units (240 unit specification) per 1 ml as a standard solution. Take 2 small tubes and add Tris buffer solution (weigh Tris 12.14g5, dissolve in 800ml water, adjust pH value to 8.0 with 6mol/L hydrochloric acid solution, dilute to 1000ml with water). Oml substrate solution (N-benzoyl-L-Arginine ethyl ester hydrochloride 14.14mg;(add Tris buffer 12.5ml to dissolve, store at 4°C) 0.5ml, mix well, after keeping the temperature in a water bath at 25°C ± 0.5°C for several minutes, add 0.2 of human test solution to one test tube, mix well, and immediately time, the temperature in the cuvette was maintained at 25°C ± 0.5°C, and 0.2ml phosphate buffer (pH 6.8) was added to the other test tube to replace the test solution as a blank until 1 minute, measure absorbance (A1) at the wavelength of 253mn by UV-Vis spectrophotometry (General rule 0401), and then pour the above two solutions back into the corresponding test tube, incubation was continued in a water bath at 25°C ± 0.5°C, and absorbance (A2) was measured by the same method at 16 minutes. Another standard solution was taken and operated by the same method.
• others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).

 

Product Packaging：

1) 1kg/bag (1kg net weight, 1.1kg gross weight, packed in an aluminum foil bag)

2) 25kg/drum (25kg net weight, 28kg gross weight; Packed in a cardboard-drum with two plastic-bags inside; Drum Size: 510mm high, 360mm diameter)

 Storage：

Stored in a cool and dry well-closed container. Keep away from moisture and strong light/heat.

Delivery：

Usually within3-5 working days after full payment.

transport：

EMS,DHL, TNT, UPS ,FEDEX, BY AIR, BY SEA

DHL Express, FedEx and EMS for quantity less than 50KG, usually called as DDU service; 

Sea shipping for quantity over 500KG; And air shipping is available for 50KG above;

For high value products, please select air shipping and DHL express for safe;

Our Service:
1. Fast Delivery: We can delivery within 24 hours upon receipt of your payment.
2. Quality can be promised. Hot sell to Worldwide.
3. Payment Terms: T/T,, t/t
4. Free Sample available at any time.
5. Tracking your order at any time. Inform your order's further new situation at any time.
6. Package: Professional packing with professional materials.

 

Packing:  
  1. Inner double plastic bags----25kg/Fiber drum (35*35*45cm, GW: 28kg, NW: 25kg); 

  2. Inner double plastic bags----5kg/Aluminum foil bag (GW: 6.5kg, NW: 5kg). 

  3. Inner double plastic bags----1kg/Aluminum foil bag (GW: 1.5kg, NW: 1kg). 

P.S.: we accept packaging customization. 

  
Delivery:   

  1. Stock products are normally shipping within 3 working days.  

  2. For rush delivery, please contact our sales team for particular arrangement. 

Shipping Details: 
  1. We ship goods via DHL, Fedex, UPS, TNT, China post, NL Post and other couriers, weight from 10g to 1000kg or even bulker. 

  2. Shipping details & shipping documents will be provided and sent by email. 

  3. We keep tracking the shippment until clients well received. 

  4. After years export shipping experience, with professional and experienced cooperated forwarders, we ensure that goods can be delivered in multiple ways safetly and efficiently. 

About us

Our company specializes in processing and selling chemical raw materials, chemical products, pharmaceutical intermediates, veterinary medicine intermediates, dye intermediates, pigments, cosmetics raw materials and chemical reagents,  

We have compalete sales and service team , information feedback vertical integration of a sound marketing network, products are sold throughout the country and exported to South Asia, Europe, America, Africa and other more than 20 countries and regions.  

Companies adhering to the "pursuit of quality, innovation and development" business philosophy, to serve as a foundation, for the survival by the quality, seek development by science and technology, adhere to quilty comes first,fair price,good sense of customer service and responsibility. in the future hebei Nengqian import and export trade Co.,Ltd will always hold "integrity, innovation" business philosophy, to achieve honesty management, on the way of specialization, internationalization,  Keep moving!  

 

FAQ: 
1. Are you a trade company or factory   
We are a  factory with our own trading company.  

2.How do you control the quality   
Our factory is equipped with professional technicians to control quality, out inspectors take sample for testing every 2 hours to ensure the quality of our production. We also accept BV, SGS or any other Third-party inspection.   

3. How long is lead time   
We deliver goods within 3 days for small order, 7-10 days for bulk order.   

4. Where is your factory located  How can I visit the factory   
 Our factory located in HEBEI, China.

5. Can i get some samples  
  Yes, we can supply free sample, but the shipping cost be paid by our customers. 

6. How to start orders or make payments  
  Proforma invoice will be sent first after confirmation of order, enclosed our bank information.Payment by T/T,  

7. How to confirm the Product Quality before placing orders  
  You can get free samples for some products,you only need to pay the shipping cost or arrange a courier to us and take the samples. 
  You can send us your product specifications and requests,we will manufacture the products according to your requests. 

8. How long is lead time

We deliver goods within 3 days for small order, 7-10 days for bulk order.

 

9. How do you treat quality complaint

  First of all, our quality control will reduce the quality problem to near zero. If there is a realquality problem caused by us, we will send you free goods for replacement or refund your loss.