Xi'an Sentian Biotechnology Co., Ltd. is one of the leading manufacturers and suppliers of custom red yeast rice extract & coq10 capsules in China. We are committed to providing high quality customized service and OEM&ODM private label service for global clients. Please feel free to buy bulk custom red yeast rice extract & coq10 capsules in stock here from our factory. Also, free sample is available.
What is Custom Red Yeast Rice Extract & CoQ10 Capsules?
Yes, the Red Rice Yeast and CoQ10 formula can be customized based on your product specifications, target market, dosage form, and formulation needs. Xi'an Sentian Biotechnology Co., Ltd. is an OEM/ODM manufacturer that can provide flexible formula development for businesses needing to develop or optimize products containing Red Yeast Rice Extract + Coenzyme Q10 (CoQ10). The formulation may be modified based on the demand for the ratio and specifications and may incorporate other compatible ingredients if desired, depending on the concept of the intended product and formulation requirements. Customers can further fine-tune the dosage form, the dose size, the specification of the ingredients, the capsule/tab format, the packaging format, the label, and the private label appearance to develop a final product that meets their brand and market requirements. Its specifications can be set based on the project requirements, including extract ratio, monacolin content, and other specifications; CoQ10 can be provided in the appropriate specification for the formulation selected. From the early stages of discussions about the formula to specification confirmation and sample preparation, packaging customization, mass production, and shipment, Sentian provides all the necessary support to customers to help them rapidly transform their idea into a commercially ready product in an integrated OEM/ODM workflow.
COA
| Test Item | Specification | Result | Test Method |
| Appearance | Red to reddish-brown capsules, uniform, intact, free from visible foreign matter | Complies | Visual Inspection |
| Identification – Red Yeast Rice Extract | Positive | Positive | HPLC / TLC |
| Identification – Coenzyme Q10 | Positive | Positive | HPLC |
| Red Yeast Rice Extract | Customized according to formulation | Complies | HPLC / Internal Method |
| Monacolin K | Customized specification according to target market and formulation | Complies | HPLC |
| Coenzyme Q10 | Customized according to formulation | Complies | HPLC |
| Citrinin | Not Detected / ≤ Applicable Regulatory Limit | Not Detected | HPLC |
| Synthetic Statins | Not Detected | Not Detected | LC-MS/MS |
| Loss on Drying | ≤8.0% | 4.30% | USP <731> |
| Disintegration | ≤30 min | 17 min | USP <2040> |
| Average Fill Weight | 95–105% of declared weight | 100.60% | Internal Method |
| Weight Variation | Complies with applicable requirement | Complies | USP <2091> |
| Lead (Pb) | ≤2.0 mg/kg | 0.18 mg/kg | ICP-MS |
| Cadmium (Cd) | ≤1.0 mg/kg | 0.07 mg/kg | ICP-MS |
| Arsenic (As) | ≤1.0 mg/kg | 0.12 mg/kg | ICP-MS |
| Mercury (Hg) | ≤0.1 mg/kg | <0.01 mg/kg | ICP-MS |
| Total Plate Count | ≤1,000 CFU/g | 110 CFU/g | USP <61> |
| Total Yeast & Mold | ≤100 CFU/g | <10 CFU/g | USP <61> |
| Escherichia coli | Absent/10 g | Absent | USP <62> |
| Salmonella | Absent/25 g | Absent | USP <62> |
| Staphylococcus aureus | Absent/10 g | Absent | USP <62> |
| Aflatoxins | ≤10 μg/kg | <2 μg/kg | HPLC |
| Residual Solvents | Complies with applicable requirements | Complies | GC |
| Pesticide Residues | Complies with applicable requirements | Complies | GC-MS/MS / LC-MS/MS |
| Net Content | ≥ Label Claim | Complies | Internal Method |
| Shelf Life | 24 Months | Complies | Stability Study |
Sentian Bio provides free samples, OEM/ODM customized products, and professional technical support. Contact us anytime at sales3@sentianbio.com or LEAVE A MESSAGE!
What quality standards do you follow?
Strict quality control is adhered to in the sourcing of raw materials, formulation, manufacture, and finished product inspection. We have established manufacturing and quality management systems that are backed by the following for our product production and manufacturing: GMP, ISO 22000, HACCP, Kosher, Halal, FDA-registered. We have our own factory that is certified with GMP and SC, and has its own dedicated production areas with controlled manufacturing processes. CoQ10 with Red Rice Yeast formulas are subject to identity and specification testing for the raw materials, microbiological parameters, moisture, and heavy metals, as well as purity testing for ingredients and characteristic component content, and other testing requirements. Red Yeast Rice Extract can also be assessed for specified monacolin content and citrinin control, and CoQ10 can be assessed based on its defined specification. Quality checks are carried out from raw materials through production and the finished products, and batch records and test sheets are used to ensure their consistency and traceability. We can also provide COAs, testing reports, and customized product specifications according to customers' requirements and destination markets for procurement and OEM/ODM projects.
Content Control
1. Raw Material Testing
Red Yeast Rice Extract and CoQ10 are checked prior to manufacturing in conformity with their approved specifications, such as identity, purity, and quality parameters.
2. Ingredient Identification
All key ingredients are verified to ensure that all ingredients are correctly identified and specified before they are released for formulation, helping to prevent raw material mix-ups.
3. Accurate Formula Weighing
The Red Yeast Rice Extract and CoQ10 are carefully weighed per the approved formula and desired dose per capsule. The ratio of ingredients can be optimized to meet the needs of the customer.
4. Controlled Blending
Controlled production conditions are used to ensure uniform distribution in the capsule batch.
5. Content Testing
The finished formulation of Red Yeast Rice Extract and CoQ10 is analyzed to verify the specified content of Red Yeast Rice Extract and CoQ10 using appropriate analytical testing. When the content of the Red Yeast Rice Extract is stipulated in the product standard, relevant measures, including monacolin content, can also be tested.
6. Batch-to-Batch Consistency
The content of ingredients is maintained constant between production batches through standardised formulas, strict weighing and documented production procedures, along with analytical testing.
7. Finished Capsule Inspection
Assessment of the finished Red Yeast Rice Capsules for appearance, fill weight, content uniformity, microbiological quality, and other specifications as may be applicable, is carried out prior to release to ensure conformity with the approved product standard.
Can You Provide Samples and a COA?
Yes. We offer Red Yeast Rice with CoQ10 Supplement samples and related quality documentation to allow evaluation, product formulation, and long-term sourcing. Customers can ask for product samples, COA, specification sheets, testing reports, and batch information regarding the Custom Red Yeast Rice Extract & CoQ10 Capsules. Samples can be made based on the agreed formula and capsule specifications for the customer to see, and then they can order bulk quantities. The COA will contain some of the most important results of the quality measurements of the batch; the specification sheet will contain the agreed quality requirements for the product and the relevant test parameters. When appropriate, testing reports can also contain analytical data on the quality attributes of the finished product and on key ingredients. The batch information and production records ensure product traceability and consistency of production runs. All throughout the OEM/ODM process, quality control includes raw materials, formulation, encapsulation, and finished product inspection, which sets a structure for repeat production and continuous supply. We pay attention to product quality assurance from raw materials to capsule, and our goal is to help the customer to build a stable and traceable supply relationship for future commercial production.
FAQ
1. Can I customize the Red Yeast Rice Extract & CoQ10 formula?
Yes. The formula is flexible and can be adjusted to fit the specifications for Red Yeast Rice Extract and CoQ10, ingredient proportions, capsule size and dosage, as well as the desired target market.
2. Can you provide samples before bulk production?
Yes. Samples can be prepared ahead of bulk production to evaluate the product before it is produced using the agreed formula and capsule specifications. OEM/ODM sample development is supported.
3. What quality documents can you provide?
Relevant documents like COA, Specification sheet, Testing reports, Batch information, etc. can be supplied as per agreed product requirements.
4. How do you maintain batch-to-batch consistency?
Consistency from raw materials to finished capsules is ensured with standardized formulas, controlled raw material specifications, documented production procedures, and incoming and outgoing quality control.
5. Can the capsule and packaging be customized?
Yes. Capsule shell options, formula, labeling, bottle configuration, and packaging can be customized according to your product requirements and brand specifications.
Production Process
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