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High Quality USP/EP/BP GMP DMF FDA Halibut-liver Oil Capsules CAS NO Producer

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  • AZ427
  • Dideu
  • China
  • Halibut-liver Oil Capsules
  • High quality
  • 99.0% Min
  • 99%-101%
  • Capsule
  • Solubility in water
  • 1.0% max
  • 0.5% Max
  • 10 ppm Max
  • H-NMR
  • 0.5% Max
  • Medicine

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Halibut-liver Oil Capsules 

Definition

Halibut-liver Oil Capsules are soft capsules containing Halibut-liver Oil diluted, if necessary, with a suitable fixed oil to a volume of 0.12  to 0.18  ml in each capsule.


The capsules comply with the requirements stated under Capsules and with the following requirements.

Content of vitamin A

3500  to 4700  IU.

Assay

Weigh 10 capsules. Open the capsules carefully without loss of shell material, express as much of the contents as possible and reserve the expressed material. Wash the shells with ether , discard the washings, allow the shells to stand at room temperature to constant weight. The difference between the weights represents the weight of the total contents. Determine the content of vitamin A in the reserved portion of the contents by the method described below and calculate the content in a capsule of average content weight.


Carry out the procedures as rapidly as possible, avoiding exposure to actinic light and air, oxidising agents, oxidation catalysts (e.g. copper and iron) and acids. 


Carry out Method A (ultraviolet absorption spectrophotometry) but if method A is found not to be valid, carry out method B (liquid chromatography).


Method A

To 1  g of the oil being examined in a round-bottomed flask, add 3  ml of a freshly prepared 50% w/w solution of potassium hydroxide and 30  ml of ethanol , boil under a reflux condenser in a current of nitrogen for 30  minutes and cool rapidly. Add 30  ml of water and extract with four 50  ml quantities of ether and discard the aqueous layer after complete separation of the final extract. Wash the combined ethereal layers with four 50  ml quantities of water and evaporate to dryness under a gentle current of nitrogen at a temperature not exceeding 30° or in a rotary evaporator at a temperature not exceeding 30° under reduced pressure. Dissolve the residue in sufficient propan-2-ol R1 to give an expected concentration of vitamin A equivalent to 10  to 15  IU per ml. Measure the absorbances of the solution at 300  nm, 310  nm, 325  nm and 334  nm and at the wavelength of maximum absorption, Appendix II B, in a suitable spectrophotometer in 1-cm specially matched cells, using propan-2-ol R1 in the reference cell.


Calculate the content of vitamin A, as all-trans-retinol, in IU per gram from the expression:

1103-1530


where

 A 325  = absorbance at 325  nm, 


 m  = weight of the oil being examined in grams,

 

 V  = total volume of solution containing 10  to 15  IU of vitamin A per ml,

 

 1830 = conversion factor for the specific absorbance of all-trans-retinol in IU.

 

The above expression can be used only if A 325  has a value of not greater than A 325,corr/0.970 where A 325,corr is the corrected absorbance at 325  nm and is given by the equation:


A 325, corr = 6.815A 325 - 2.555A 310 - 4.260A 324 


A designates the absorbance at the wavelength indicated by the subscript.


If A 325  has a value greater than A 325,corr/0.970, calculate the content of vitamin A from the expression:


1103-1531

The assay is not valid unless the wavelength of maximum absorption lies between 323  nm and 327  nm and the absorbance at 300  nm relative to that at 325  nm is at most 0.73.


Method B

Carry out the method for liquid chromatography , Appendix III D, using the following solutions. Prepare solution (1) in the following manner. To 2  g of the oil being examined in a round-bottomed flask add 5  ml of a freshly prepared 10% w/v solution of ascorbic acid and 10  ml of a freshly prepared 80% w/v solution of potassium hydroxide and 100  ml of ethanol , boil under a reflux condenser on a water bath for 15  minutes. Add 100  ml of a 1% w/v solution of sodium chloride and cool. Transfer the solution to a 500  ml separating funnel rinsing the round-bottomed flask with about 75  ml of a 1% w/v solution of sodium chloride and then with 150  ml of a mixture of equal volumes of light petroleum R3 and ether R . Shake for 1  minute and when the layers have separated completely, discard the lower layer and wash the upper layer with 50  ml of a 3% w/v solution of potassium hydroxide in a 10% v/v solution of ethanol and then with three 50-ml quantities of a 1% w/v solution of sodium chloride . Filter the upper layer through 5  g of anhydrous sodium sulphate on a fast filter paper into a 250  ml flask suitable for a rotary evaporator. Wash the funnel with 10  ml of fresh extraction mixture, filter and combine the upper layers. Distil them at a temperature not exceeding 30° under reduced pressure (water ejector) and fill with nitrogen when evaporation is completed. Alternatively evaporate the solvent under a gentle current of nitrogen at a temperature not exceeding 30°. Dissolve the residue in propan-2-ol , transfer to a 25-ml graduated flask and dilute to 25  ml with propan-2-ol . Gentle heating with the aid of ultrasound may be required. (A large fraction of the white residue is cholesterol.) Solution (2) is a solution of retinyl acetate EPCRS in 2- propan-2-ol R1 containing about 1000  IU per ml of all-trans-retinol. The exact concentration of solution (2) is assessed by ultraviolet absorption spectrophotometry, Appendix II B. Dilute the solution with propan-2-ol R1 to a presumed concentration of 10  to 15  IU per ml and measure the absorbance at 326  nm in matched 1-cm cells using propan-2-ol R1 in the reference cell. Calculate the content of vitamin A in IU per ml of solution (2) from the following expression, taking into account the assigned content of retinyl acetate EPCRS :


1103-1532

where

 A 326  = absorbance at 326  nm,

 

 V 2  = volume of the diluted solution,

 

 V 1  = volume of reference solution (a) used,

 

 1900  = conversion factor for the specific absorbance of retinyl acetate EPCRS in IU.

 

Prepare solution (3) in the same manner as solution (1) but using 2  ml of solution (2) in place of the oil being examined. The exact concentration of solution (3) is assessed by ultraviolet absorption spectrophotometry, Appendix II B. Dilute solution (3) with propan-2-ol R1 to a presumed concentration of 10  to 15  IU per ml of all-trans-retinol and measure the absorbance at 325  nm in matched 1-cm cells using propan-2-ol R1 in the reference cell. Calculate the content of all-trans-retinol in IU per ml of solution (3) from the expression:


1103-1533

where

 A 325  = absorbance at 325  nm,

 

 V 3  = volume of the diluted solution,

 

 V 4  = volume of reference solution (b) used,

 

 1830 = conversion factor for the specific absorbance of all-trans-retinol in IU.

 

The chromatographic procedure may be carried out using (a) a stainless steel column (25  cm × 4.6  mm) packed with octadecylsilyl silica gel for chromatography (5 µm to 10 µm), (b) as mobile phase at a flow rate of 1  ml per minute a mixture of 3  volumes of water and 97  volumes of methanol and (c) as detector a spectrophotometer set at 325  nm.


Inject in triplicate 10 µl of solutions (1) and (3). The retention time of all-trans-retinol is 4  to 6  minutes.


The assay is not valid unless (a) the chromatogram obtained with solution (1) shows a peak corresponding to that of all-trans-retinol in the chromatogram obtained with solution (3), (b) when using the method of standard additions to solution (1) there is greater than 95% recovery of the added retinyl acetate EPCRS and (c) the recovery of all-trans-retinol in solution (3) as assessed by direct absorption spectrophotometry is greater than 95%.


Calculate the content of vitamin A using the following expression:

1103-1534

where

 A 1 = area of the peak corresponding to all-trans-retinol in the chromatogram obtained with solution (1),

 

 A 2  = area of the peak corresponding to all-trans-retinol in the chromatogram obtained with solution (3),

 

 C  = concentration of retinyl acetate EPCRS in solution (2) as assessed before the saponification in International Units per millilitre (1000  IU per ml),

 

 V  = volume of solution (2) treated (2  ml),

 

 m  = weight of the oil being examined in solution (1) (2  g).

Storage

Halibut-liver Oil Capsules should be protected from light and stored at a temperature not exceeding 20°. When stored under these conditions, they may be expected to retain their potency for at least 3 years after the date of preparation.

Labelling

The label states that each capsule contains 4000  IU (Units) of vitamin A activity.




The packaging can be customized. the shipping term can be by sea, by air, and sample or small quantity can be shipped by DHL, FEDEX, EMS and TNT.

Capsules 1CapsulesCapsules 106

a) Free sample can be supplied.

b) Guide our clients by professional knowledge and teach them how to use our product after sales.

c) Accept SGS,BV any other third-party inspection before loading.

d) High quality best price Guaranteed.


Why do you choose Dideu Industries as your partner?


A) High quality can be guaranteed. Dideu Industries since 1975 are reputed chemical manufacturer and are Certified by ISO 9001;2015 and have GMP certification.Free sample can be arranged before shipment and SGS,BV and other third party inspection company are accepted before loading.For regular customers, we accept L/C 180 Days, D/P,D/A payment term. If there is any quality problem after goods arrive. Dideu Industries will do fully payment refund.


B) Best price can be guaranteed. As Dideu Industries are integrated pharmaceuticals and chemicals producer, the production cost can be controlled and price will be definitely more competitive than China trading companies.


C) Professional enginners from Dideu Industries will give professional usage guide and services after sales.


D)Dideu Industries work 7×24 hours and your request will be processed by our professional staff in different shift period.


Dideu Industries is one of the largest producer for general chemical, pharmaceutical, nutrition additive, natural extracts, agrochemical and Daily-Use Chemical in China and is headquartered in Shaanxi, China. The Dideu Group comprises subsidiaries and joint ventures in more than 10 countries and operates six integrated production sites and 21 other production sites in Europe, Asia, Australia, Americas and Africa.Its headquarters is located in Xi’An,China. Dideu has customers in over 200 countries and supplies products to a wide variety of industries.


At the end of 2014, the company employed more than 13000 people. In 2014, Group Dideu posted sales of 30 billion and income from operations before special items of about 7.5 billion. The company is currently expanding its international activities with a particular focus on Asia countries. Between 1990 and 2005, the company invested 5.2 billion in Asia, for example in sites near Guangxi,Yunnan, Sichuan, Shaanxi China,Mangalore in India,Bangkok, Thailand,Hanoi, Vietnam etc.


Dideu Industries Consist Of Five Industry Chains:


I)Pharmaceutical Industries

II)Nutrition Additive Industries

III)Daily-Use Chemical Products Industries & Agrochemicals

IV)Environmental Friendly Chemical And Chemurgy Industries

V)Petrochemical Industries

VI)General Chemical Industry


At Dideu, we redefine chemistry to make the world better - and have been doing so for 75 years. As one of the world's leading chemical company, we combine economic success with environmental protection and social responsibility.Through science and innovation we enable our customers in nearly every industry to meet the current and future needs of society.


At Dideu, we create chemistry for a sustainable future with science for a better life.Dideu is a Life Science company with a long and glorious history and core competencies in the areas of health care and agriculture. With our innovative products, we are contributing to finding solutions to some of the major challenges of our time. The growing and increasingly aging world population requires improved medical care and an adequate supply of food. Dideu is improving people's quality of life by preventing, alleviating and treating diseases. And we are helping to provide a reliable supply of high quality food, feed and plant based raw materials.We develop new molecules for use in innovative products and solutions to improve health. Our research and development activities are based on a profound understanding of the biochemical processes in living organisms.Our goal is to achieve and sustain leadership positions in our markets, thus creating value for our customers, stockholders and employees. To this end, our strategy is designed to help solve some of the most pressing challenges facing humankind, and by doing this exceptionally well we aim to strengthen the company's earning power. 


We are committed to operating sustainably and addressing our social and ethical responsibilities as a corporate citizen, while at the same time respecting the interests of all our stakeholders. Employees with a passion for innovation enjoy excellent development opportunities at Dideu.Exclusive Focus on the Life Science BusinessesFollowing the economic and legal independence of our former Material Science subgroup.Dideu has charted the course for its successful development as a Life Science company. Our Life Science businesses hold leading positions in innovation driven growth markets. Together they make up a strong, attractive and balanced portfolio that is resistant to fluctuations in demand and to potential risks.The previous structure comprising a strategic management holding company and operational subgroups has thus been replaced by an integrated organization under the umbrella of the strong Dideu brand. The company's operations are managed in three divisions Pharmaceuticals, Consumer Health and Crop Science and the Animal Health business unit.The business continues to be supported by the corporate functions, Dideu Business Services and the service company Currenta, while Technology Services is being integrated into Dideu Group, forming the Engineering and Technology function.


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