Brazil pharmaceutical excipient silica

50 FAQs with Answers (English Version) For General-Purpose Precipitated Silica (Food / Oral Care / Pharma / Cosmetics as core, Industrial / Feed as secondary), tailored for the Brazilian market. 1. Product Basics Q1: What production process is used for this general-purpose silica? A: This product is manufactured via the wet precipitation process, where amorphous hydrated silica is formed through the neutralization reaction between sodium silicate and sulfuric acid. The fully controlled production process ensures high batch-to-batch consistency. Q2: What is the core chemical composition of the product? Is it crystalline or amorphous? A: The core component is amorphous precipitated hydrated silica, free of crystalline silica. It features stable chemical properties and no biotoxicity. Q3: What are the core application areas of this general-purpose grade? How are primary and secondary applications defined? A: Its four primary application sectors are food, oral care & toothpaste, pharmaceutical excipients, and cosmetics. Industrial fillers and feed anti-caking agents are secondary applications. One grade covers multi-category production needs. Q4: What is the difference between general-purpose silica and single application-specific grade (e.g., pure toothpaste abrasive grade)? A: Single application-specific grades are optimized for one single sector. This general-purpose grade meets the compliance requirements of food, pharmaceutical and personal care industries on core indicators, adapts to multi-category production, and reduces customers' procurement and inventory costs. Q5: Who is the manufacturer of this product and where is the production base located? A: It is produced by Zhongqi Shandong Silicon Material Co., Ltd., based in Shandong, China. We are a national high-tech enterprise with 8 patents for silica production technology. Q6: Is this product classified as a hazardous chemical? A: No. It is an inert inorganic powder, non-toxic, non-corrosive, non-flammable and non-explosive. It is not a hazardous chemical and has no special regulatory requirements for conventional transportation and storage. 2. Core Technical Parameters Q7: What is the minimum silica purity on an ignited basis? A: The SiO₂ content is ≥97.5% on an ignited basis, with extremely low impurity content, meeting the high-purity requirements of food and pharmaceutical grades. Q8: What is the standard range of median particle size (D50)? Is customized adjustment available? A: The standard median particle size (D50) is 10–15μm. The particle size distribution range can be customized according to customers' different application requirements. Q9: What is the minimum standard of CIE whiteness L value?* A: The CIE whiteness L* value of the product is ≥97.5. Its excellent whiteness enhances the appearance quality and visual brightening effect of white pastes and powder products. Q10: What is the stated RDA value range? Is it only applicable to toothpaste applications? A: The standard RDA value range is 120–150. This indicator is set exclusively for toothpaste abrasive scenarios and is not a core evaluation indicator for other industry applications. Q11: What is the pH range of 5% aqueous suspension? Does it affect formulation compatibility? A: The pH value of 5% aqueous suspension is 6.5–7.3, nearly neutral. With strong chemical inertness, it has excellent compatibility with most neutral and weakly acidic formulation systems. Q12: What are the standard ranges of DBP oil absorption and BET specific surface area respectively? A: The standard range of DBP oil absorption is 80–120 cm³/100g, and the standard range of BET specific surface area is 100–140 m²/g. Both indicators can be customized as required. Q13: What are the control limits for heavy metals and microorganisms respectively? A: Heavy metal limits: Arsenic ≤1ppm, Lead ≤2ppm, Mercury ≤0.5ppm. Microbial limit: Total aerobic plate count ≤50 cfu/g, meeting the safety control requirements of food and pharmaceutical grades. 3. International Qualifications & Certifications Q14: What international authoritative certifications does this product currently hold? A: It has obtained multiple international authoritative certifications including USP/NF, ISO 22000, GMP, ISO 9001, HALAL, KOSHER, FDA food contact material, and FAMIQS. Q15: Does it comply with USP/NF pharmacopeia standards? Can it be used for pharmaceutical preparation production? A: It fully complies with the USP/NF Silicon Dioxide Monograph, and can be used as a pharmaceutical excipient in the production of tablets, powders, capsules and other pharmaceutical preparations. Q16: Is it certified with ISO 22000 food safety management system? A: Yes, it has passed ISO 22000:2018 food safety management system certification, and the entire production process complies with food-grade safety control standards. Q17: Has it passed HALAL and OU KOSHER certification? A: Yes, it has obtained SHC HALAL certification and OU KOSHER certification, meeting the compliance access requirements of halal and kosher markets in Brazil and worldwide. Q18: Does the feed application hold FAMIQS quality system certification? A: Yes, the feed application scenario has passed FAMIQS feed additive quality system certification, complying with global feed industry safety specifications. Q19: Does it comply with FDA food contact material safety standards? A: Yes, it has passed FDA food contact material safety certification, and can be compliantly used in food contact materials and food processing aid scenarios. Q20: What official quality and compliance documents can be provided with each batch of goods? A: A full set of technical compliance documents including COA (Certificate of Analysis), TDS (Technical Data Sheet), MSDS (Material Safety Data Sheet) and method validation reports can be provided for each batch. 4. Brazil Local Compliance Q21: Does this product support ANVISA registration in Brazil? A: Yes. All product indicators and certifications meet ANVISA's access requirements for food, cosmetics and pharmaceutical excipients. We can provide a full set of documents to assist customers in completing registration and declaration. Q22: Can you provide a full set of technical documents required for Brazilian import customs clearance? A: Yes. We can provide a full set of customs clearance documents meeting Brazilian customs requirements, including certificate of origin, inspection reports, certification documents, etc., to ensure a smooth customs clearance process. Q23: Does the product comply with local safety regulations for food and cosmetics in Brazil? A: The product complies with the safety technical specifications for food and cosmetic raw materials under the jurisdiction of ANVISA, and key indicators such as heavy metals and microorganisms all meet the standards. Q24: What supporting compliance services can you provide for the Brazilian import process? A: We can provide supporting services including translation of product technical documents, assistance with notarization of certification documents, standardized sorting of customs clearance documents, and technical Q&A for registration and declaration. 5. Toothpaste & Oral Care Application Q25: Can this general-purpose silica be directly used in whitening toothpaste formulations? A: Yes. The standard grade has an RDA value of 120–150 with efficient stain removal and polishing performance, and can be directly used in whitening toothpaste and deep-cleaning toothpaste formulations. Q26: What is the recommended dosage in whitening toothpaste formulations? A: The recommended dosage in whitening toothpaste formulations is 18%–25%, which can be flexibly adjusted according to the target RDA value and cleaning performance requirements. Q27: How is its compatibility with fluorides such as sodium fluoride and sodium monofluorophosphate? A: The product is chemically inert with a nearly neutral pH, and has excellent compatibility with active ingredients such as sodium fluoride and sodium monofluorophosphate, maintaining stable fluoride availability over a long shelf life. Q28: Will an RDA value of 120–150 cause excessive enamel wear? A: No. This RDA range complies with international oral care safety standards. While efficiently removing extrinsic stains, the enamel wear level remains within the clinically safe range. Q29: Can it be blended with low-abrasion silica to adjust abrasion intensity? A: Yes. It can be blended with low-abrasion thickening silica in proportion to precisely adjust the RDA value and paste mouthfeel, adapting to toothpaste products with different positioning. 6. Food Industry Application Q30: What are the main functions of this silica in food processing? A: It is mainly used as an anti-caking agent, flow aid, flavor carrier and processing aid in food, preventing powder food from caking and improving powder fluidity. Q31: What is the conventional dosage range in food formulations? A: The conventional dosage in food is 0.5%–5%, and the specific dosage shall be determined according to different food categories and process requirements. Q32: Which food categories is it mainly suitable for? A: It is widely applicable to various food processing scenarios such as powdered seasonings, instant beverages, milk powder, creamer, salt, powdered sugar, and beer clarifiers. Q33: Can it be used as a carrier for food flavors and powder additives? A: Yes. With controllable pore structure and excellent adsorption performance, it can be used as an adsorption carrier for powder additives such as flavors and nutritional fortifiers. 7. Pharmaceutical Industry Application Q34: What excipient functions does this product mainly perform in the pharmaceutical field? A: In the pharmaceutical field, it is mainly used as a glidant, anti-adherent and carrier, which can improve powder fluidity, optimize tableting process performance, and enhance preparation stability. Q35: What is the conventional dosage in tablets, capsules and powders? A: The conventional dosage in tablets, capsules and powders is 0.1%–3%, and the specific dosage shall be adjusted according to the preparation formula and process requirements. Q36: Can you support the registration and filing of local pharmaceutical products in Brazil? A: Yes. We can provide a full set of technical documents and validation materials complying with USP/NF standards to assist customers in completing the registration and filing of local pharmaceutical products in Brazil. 8. Cosmetics & Personal Care Application Q37: What are the main application effects of this silica in cosmetics? A: In cosmetics, it performs functions such as thickening, thixotropy adjustment, matting, oil absorption and soft focus, improving paste skin feel and formulation stability. Q38: Can it be added to skincare products such as scrubs, creams and lotions? A: Yes. It can be used as mild abrasive particles in scrubs, and also added to creams and lotions to adjust rheological properties and improve product skin feel. Q39: Is the product irritating to the skin? What is its safety level? A: The product is an amorphous inert powder, non-irritating to the skin and non-sensitizing. It complies with cosmetic raw material safety standards and can be safely used in various skincare and makeup products. Q40: Is it suitable for makeup products such as loose powder and foundation? A: Yes. Its high whiteness and soft focus properties can improve makeup effect, and its oil absorption performance can extend makeup staying power. It is suitable for various makeup categories such as loose powder, pressed powder and foundation. 9. Industrial & Feed Supplementary Applications Q41: What are the common application directions of this product in industrial scenarios? A: In industrial scenarios, it can be used as a coating matting agent, silicone rubber reinforcing filler, industrial adsorbent, paper filler, etc. It is a general-purpose industrial inorganic functional filler. Q42: What is the main function of adding it to feed? What is the conventional dosage? A: It is mainly used as an anti-caking agent and nutrient carrier in feed, preventing premixes and feed additives from caking and improving powder fluidity. The conventional dosage is 0.5%–3%. Q43: Does the feed application comply with local feed safety regulations in Brazil? A: Yes. The product holds FAMIQS certification, with heavy metal and microbial indicators meeting the standards, complying with Brazil's feed raw material import safety requirements. 10. Usage, Operation & Storage Q44: At which production stage is it recommended to add the silica powder? A: It is recommended to add it during the dry powder blending stage. After fully mixing with the powder base material, add liquid components to avoid agglomeration. Q45: How to avoid powder agglomeration and ensure uniform dispersion during production? A: Control the feeding sequence: pre-mix with dry powder first, then add liquid gradually. Meanwhile, ensure sufficient mixing time and shear strength to avoid local agglomeration. Q46: What are the storage requirements and shelf life of the product? A: It shall be stored in a sealed package in a cool and dry environment to avoid moisture. The shelf life is 24 months when the original package is unopened. Q47: Can products with slight caking during storage still be used normally? A: Slightly caked products can be used normally after crushing and sieving, without affecting product performance. If severe moisture-induced caking occurs, it is recommended to stop using them. 11. Packaging, Trade & Supply Q48: What are the standard packaging specifications? Is customized packaging and shipping mark supported? A: The standard packaging is 10kg, 15kg, 20kg export-standard waterproof kraft paper bags. Customized packaging specifications, printed shipping marks and brand logos are supported. Q49: What trade terms are supported? Which major Brazilian ports can be reached directly? A: We support multiple trade terms including FOB Qingdao, CIF/CFR Santos/Rio de Janeiro, and DDP major Brazilian cities, covering Brazil's core ports and inland cities. Q50: What is the minimum order quantity? How do you ensure stable supply for large-volume orders? A: The conventional minimum order quantity is one 20ft container. With a large-scale production base and stable production capacity, we can ensure continuous and stable supply for large-volume orders through advance production scheduling.