NMN Bulk Powder

NMN Bulk Powder Supplier:

NMN bulk powder of Guanjie is high quality and low price. Guanjie Biotech is a manufacturer of NMN powder with 99.5% purity, which is white crystalline powder. We use both freeze-drying and vacuum drying technologies, no harmful solvent residue, high purity and high stability.

Our Nicotinamide mononucleotide(NMN) with different bulk densities as below:
● 0.15g/ml, applied in solid drinks(freezing dry process)

● 0.55g/ml: can fill 0#, 00# capsule(vacuum dry process)
● 0.75g/ml: can fill 1#, 2# capsule(vacuum dry process)
All the purity is more than 99.5%

 

Guanjie a national high-tech enterprise integrating R&D, production and sales on the basis of multidisciplinary cross-application. There are two production bases in Xi 'an city and Baoji city. Guanjie has its own factory, which has passed many international certifications to ensure the high quality and stable supply of products. At present, we focus on enzyme catalysis industry chain, and its products include anti-aging coenzymes and customized technical service solutions for customers. Our clients are from 50 countries and get high praise.

 

Chromatogram

 

Method of Analysis

β-NMN/β-Nicotinamide Mononucleotide

Formula：C11H15N2O8P

Formula weight：Mr = 334.2;

CAS No.：1094-61-7

Maximum absorption wave length：260 nm

 

Specification

● Nicotinamide Mononucleotide(Vacuum-dried)

TEST	METHOD	ANALYTE	SPECIFICATION	RESULT
Identify	NMR	Nicotinamide Mononucleotide	Conforms to structure	Conforms to structure
Purity	HPLC/UV(wt%)	Nicotinamide Mononucleotide	≥99%	99.87%
Moisture	Karl Fischer	Water	≤5%	0.15%
Sodium content			≤1%	0.02%
Bulk density		Weight density	>0.55g/ml	0.54g/ml
PH value		in water at 100mg/ml	2.0-4.0	3.07
Heavy Metals		Lead Arsenic	<5 ppm	0.01ppm
			<5 ppm	0.01ppm
Microbial	USP<2021> USP<2022>	Total Plate Count E. coli	< 750CFU/g < 30MPN/100g	60CFU/g N.D.
Appearance	NA	Color, Form	White to yellowish powder	White powder

 

 

● Nicotinamide Mononucleotide(Freeze-dried)

TEST	METHOD	ANALYTE	SPECIFICATION	RESULT
Identify	NMR	Nicotinamide Mononucleotide	Conforms to structure	Conforms to structure
Purity	HPLC/UV(wt%)	Nicotinamide Mononucleotide	≥99%	99.94%
Moisture	Karl Fischer	Water	≤5%	0.16%
Sodium content			≤1%	0.01%
Bulk density		Weight density	<0.20g/ml	0.16g/ml
PH value		in water at 100mg/ml	2.0-4.0	3.10
Heavy Metals		Lead Arsenic	≤1.0 ppm	0.01ppm
			≤1.0 ppm	0.01ppm
Microbial	USP<2021> USP<2022>	Total Plate Count E. coli	≤ 750CFU/g ≤ 30MPN/100g	50CFU/g N.D.
Appearance	NA	Color, Form	White to yellowish powder	White powder

 

Flow chart:

 

● Appearance: White to yellowish powder

 

● PH value in water:

( NMN :500mg , Pure water 5ml. ) Dissolved nmn powder in pure water, make its concentrations in 100mg/ml,testing by pH meter. After 3 Min take the results .

 

● Acceptance criterion:

PH value : 2.0~4.0.

 

● HPLC Purity

Column: Xtimate C18 (4.6 × 250 nm, 5 μm)

Mobile phase A: 20mmol/L NaH2PO4 buffer solution ( 2.4g NaH2PO4 dissolved in water, using 6 mol/L sodium hydroxide solution to adjust the pH to 3.5 , dilute to 1000ml, and filter with 0.22 μm microporous membrane (aqueous membrane) ).

Mobile phase B: methanol (chromatographic grade) Elution gradient

 

TIME(Min)	Mobile phase A(%)	Mobile phase B(%)
0	99
4	99	1
5	95	5
10	85	15
12	80	20
12.1	99	1
16	99	1

Flow rate: 1.0ml/min ; Column temperature: 25°C; Detection wavelength: 260nm ;Injection volume: 20μl

 

Test sample (0.35mg/ml): Take the test sample out to the room condition (temperature at 25 ° C, 40%-60% humidity) and get 0.35mg test sample when its temperature come to normal .then add pure water to make a solution containing 0.35mg per 1ml .

Reference substance (0.35mg/ml): Take NMN Bulk Powder out to the room condition (temperature at 25 ° C, 40%-60% humidity) and get 0.35mg test sample when its temperature come to normal , then add pure water to make a solution containing 0.35mg per 1ml .

 

Precisely take 20μl of the above test solution and the reference solution into the liquid chromatograph, and record the chromatogram. The retention time of the main peak of the test solution is consistent with the retention time of the main peak of the reference solution.

 

Acceptance criterion: Purity >99.5%

● Water Contents

Purified water: 10~30mg , the solvent is methanol (AR) and formamide (AR) in a titration solvent bottle. Mix in a volume ratio of 2:1 and shake well. The commercially available Karl Fischer test solution is directly calibrated with a moisture analyzer, and the calibration is performed three times in succession. The RSD of the three results should not exceed 3%. If it exceeds 3%, the calibration is performed once again, and the error data is discarded, and the RSD is recalculated until The RSD of 3 of the results was less than 3%.

 

Acceptance criterion: Water content ≤ 5% .

● Sodium contents

Precisely weigh the sodium chloride (0.2541g or the amount of sodium ion reference substance 1.0ml) as reference substance (analytically pure) (obtained in an oven at 110 ° C for 4 hours) , dissolve to deionized water and make its concentration is about 10ppm;

100mg test sample, dissolved in deionized water, and make its concentration is about 2mg / ml, according to the "HQC-SOP-68 cation test standard operating procedures" to determine, respectively, accurately take the sodium chloride reference product, the test solution into the ion chromatograph The chromatogram was recorded, and the sodium content was calculated by an external standard method.

 

Calculation formula:

S is the peak area;

m is the sample amount;

V is the dilution volume;

M is the percentage of the labeling of the sodium chloride reagent;

23 is the relative atomic mass of sodium;

58.5 is the relative molecular mass of sodium chloride;

0.01 is a dilution factor of 100 times diluted by a commercially available sodium ion standard solution (1000 ppm).

Acceptance criterion:Sodium content ≤ 1%

 

Stability

1.Stability Test Methods

Introduction:

The purpose of stability testing is to provide evidence on how the quality of NMN bulk 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 NMN powder 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, 18, 24 and 36 months. The results to date demonstrate that NMN is stable at 25±2℃temperature and 60±5% humidity conditions.

 

● Accelerated Studies:

The samples of NMN 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 nicotinamide mononucleotide bulk is stable at 40±2℃ temperature and 75±5% humidity conditions.

2.Stability Test Results

The following pages summarize the Accelerated and Long Term Stability Testing results available to date for three batches of NMN. As more data becomes available, we commit to forward this data so that it may be included as annual updates to the NMN Product Drug Master File.

 

NMN Accelerated Stability Study

Batch No: CT020125 Temperature: 40±2℃ Humidity: 75±5% Mfg. Date: 01/15/2012

Container: Duplicates commercial container (PE & PE coated Al bags in Aluminum canister)

Impurities (By HPLC)
Test Frequency	Appearance	Identity by UV	Loss on Drying	Assay (by HPLC)	Total Impurities	Single Unknown Impurity	Total Unknown Impurities
Specs	To Pass	complies	<1.0%	≥99.0%	<1.0%	<0.1%	<0.5%
Initial		complies	0.50	99.40	0.62	Max: 0.06	0.21
1M		complies	0.51	99.39	0.60	Max: 0.07	0.20
2M		complies	0.49	99.40	0.57	Max: 0.06	0.19
3M		complies	0.48	99.38	0.59	Max: 0.07	0.18
6M		complies	0.50	99.38	0.63	Max: 0.07	0.21

 

NMN Long Term Stability Study

Batch No: 020123 Temperature: 25±2℃ Humidity: 60±5% Mfg. Date: 01/15/2012

Container: Duplicates commercial container (PE & PE coated Al bags in Aluminum canister)

Impurities (By HPLC)
Test Frequency	Appearance	Identity by UV	Loss on Drying	Assay (by HPLC)	Total Impurities	Single Unknown Impurity	Total Unknown Impurities
Specs	To Pass	Complies	<1.0%	≥99.0%	<1.0%	<0.1%	<0.5%
Initial		Complies	0.47	99.35	0.67	Max: 0.06	0.24
3M		Complies	0.50	99.38	0.65	Max: 0.07	0.23
6M		Complies	0.48	99.40	0.66	Max: 0.08	0.25
9M		Complies	0.50	99.33	0.66	Max: 0.07	0.24
12M		Complies	0.46	99.35	0.68	Max: 0.07	0.23
18M		Complies	0.48	99.28	0.66	Max: 0.06	0.23
24M		Complies	0.50	99.30	0.65	Max: 0.06	0.24
36M		Complies	0.51	99.33	0.65	Max: -.07	0.23

 

3. Degradation Study

The purpose of the degradation study is to determine if the HPLC method used by our facility for NMN bulk powder release and stability studies will detect impurities and as a result is stability indicating. Two lots on stability, CT990123, CT990124 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

 

The equipment used for this study was:

- HPLC: Waters 600, USA

- Ultrasonic De-gasifier: JL-120, Shanghai, China

- Column: Bondapak C₁₈, 3.9mm x 300mm, Waters, USA

- Water Bath

- Ultraviolet lamp

- Analytical Balance

- 100mL Measuring Flasks

- 10mL Pipettetes

 

The study was performed as follows:

① Place 0.4g of NMN in a 100mL measuring flask and add acetonitrile to a total volume of 100mL.

② Place 10.0mL of the solution from Step 1 in five separate 100mL measuring flasks.

A. Add 20mL of 0.00001N NaOH to the first two flasks, cover and place in a boiling water bath for one hour.

B. Add 20mL of 0.04N HC1 to the second flasks, cover and place in a boiling bath for one hour.

C. Add 10mL of 10% Peroxide to the third pair of flasks; shake for 2 minutes and allow to stand for 30 minutes.

D. Heat the fourth pair of flasks to 60℃ and maintain this temperature for seven days.

E. Place the fifth pair of flasks under an ultraviolet lamp for seven days.

 

④ Prepare a reference standard for each sample by placing 15mg of NMN in a 100mL measuring flask and q. s. to 100mL with reagent grade solvent.

 

⑤ To adjust, the following is necessary.

A. Use 20mL of 0.04N HC1 to neutralize the 0.00001N NaOH in the first two flasks.

B. Use 20mL of 0.00001N NaOH to neutralize the 0.04N HC1 in the second two flasks.

C. Adjust the volumes of all five flasks to 100mL with mobile phase after the required conditions have been met.

 

⑥ Check all 12 flasks on the HPLC for a minimum of 30 minutes for each run to demonstrate that the method is stability indicating. The operating conditions or the HPLC are the same as those defined in Quantitative Analysis of NMN by HPLC. NMN CT020123, CT020124 as used in this degradation study.

 

Conclusion

The degradation study demonstrates that pure NMN powder is most stable when exposed, 0.04N Hydrochloric Acid, 0.00001N Sodium Hydroxide and Heat at 60℃, in that order. NMN is more unstable when exposed to peroxide, UV light. We can, therefore, conclude that the HPLC method used by Shaanxi Guanjie Technology Co., Ltd will detect degradants for both stability studies and finished product testing/release. The method is, therefore, stability indicating.

 

Functions:

● Anti-Aging: 

NMN's ability to increase NAD+ levels in the body has made it a popular subject in the anti-aging field. NAD+ decline has been associated with aging-related diseases and cellular deterioration. By enhancing with NMN, it is accepted that the NAD+ levels could be raised, possibly dialing back the maturing system, further developing cell capability, and lessening the gamble old enough related sicknesses.

 

● Sports and Wellness: 

NMN is used in the games and wellness industry. Competitors and wellness fans are keen on the expected advantages of NMN bulk powder supplementation to upgrade energy levels, further develop perseverance, and help in recuperation. Nonetheless, it is vital to take note of that further exploration is expected to approve its consequences for practice execution in people.

 

● Cosmetics: 

NMN has also found applications in the cosmetics industry due to its potential anti-aging properties. Some skincare items guarantee to integrate NMN as a fixing to advance young looking skin, further develop skin flexibility, and decrease wrinkles.  

 

● Customized Medication:

NMN supplementation and NAD+ treatment stand out in the field of customized medication. Constant monitoring and fine-tuning of an individual's NAD+ levels may provide personalized interventions for various diseases

 

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㎡.

 

Product Qualification

We are nicotinamide mononucleotide manufacturer. NMN Bulk Powder is produced in a clean working environment and every step of the process is conducted by highly qualified professionals.

 

Testing Center: 

Both the production processes of manufacture and nmn powder wholesale itself meet all international standards. And if you need our testing report, we can provide you.

 

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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